FDA 510(k) · Beijing Choice Electronic Technology
K160268: Fingertip Pulse Oximeter MD300CG11/MD300CG51 (Beijing Choice Electronic Technology Co., Ltd.)
Beijing Choice Electronic Technology Co., Ltd. received FDA 510(k) K160268 for Fingertip Pulse Oximeter MD300CG11/MD300CG51, with a decision date of Oct 14, 2016 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K160268 |
|---|---|
| Pathway | 510(k) |
| Applicant | Beijing Choice Electronic Technology Co., Ltd. |
| Device name | Fingertip Pulse Oximeter MD300CG11/MD300CG51 |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Feb 2, 2016 |
| Decision date | Oct 14, 2016 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Traditional |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
Statement Fingertip Pulse Oximeter Section II Indication for Use Statement Indication for Use 510(k) Number (if known): ___K160268________ Device Name: Fingertip Pulse Oximeter MD300CG11/MD300CG51 Indications for Use: The Fingertip Pulse Oximeter MD300CG11/MD300CG51 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent, child and infant patient with the fingers between 0.9 - 2.2 cm (0.4 - 0.9 inch) thick in hospital. Prescription Use Ĝ Over-The-Counter Use _______ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) II-1 Premarket Notification 510(k) Submission - Section III 510(k) Summary Fingertip Pulse Oximeter Section III 510(k) Summary This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92. The assigned 510(K) number is K160268 3.1 Date of Submission: Sep. 13, 2016 3.2 Sponsor Information Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 4104, No.A12 Yuquan Road, Haidian District, Beijing 100143, P.R.China Contact Person: Mr. Lei Chen Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No.9 Shuangyuan Road, Badachu Hi -tech Zone, Shijingshan District, Beijing, P.R. China, 100041 Phone: +86-10-88798300 Ext 6020 Fax: 215-4052545 3.3 Proposed Device Information Device Common or Usual Name: Pulse Oximeter Device Trade or Proprietary Name: Fingertip Pulse Oximeter Model: MD300CG11/MD300CG51 Classification Name: Oximeter Product Code: DQA Regulation Number: 870.2700 Panel: Anesthesiology Class: II 3.4
Extracted automatically from FDA's 510(k) summary. It can contain extraction errors and is not a verified quote. Read the wording in the FDA PDF before relying on it.
Predicates parsed from FDA documents
FDA numbers found next to the word "predicate" in the summary. The list can include reference devices; check the PDF for which device is the primary predicate.
- K131047 FINGERTIP PULSE OXIMETER (Beijing Choice Electronic Technology)
ChatPPG interpretation
A 510(k) decision of "substantially equivalent" means FDA found the device as safe and effective as a legally marketed predicate. FDA's word for this is cleared, not approved. The clearance covers the device and indications in this submission; it does not extend to other features or versions of the same product that were not part of it. See FDA cleared vs approved.
Product code DQA is "Oximeter", class 2, 21 CFR 870.2700.
Our labels for filtering: claim SpO2 / pulse oximetry, sensor Finger PPG. These are heuristics, not FDA fields.