FDA 510(k) · Beijing Choice Electronic Technology
K142888: Fingertip Pulse Oximeter (Beijing Choice Electronic Technololgy Co., Ltd.)
Beijing Choice Electronic Technololgy Co., Ltd. received FDA 510(k) K142888 for Fingertip Pulse Oximeter, with a decision date of Feb 20, 2015 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K142888 |
|---|---|
| Pathway | 510(k) |
| Applicant | Beijing Choice Electronic Technololgy Co., Ltd. |
| Device name | Fingertip Pulse Oximeter |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Oct 2, 2014 |
| Decision date | Feb 20, 2015 |
| 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
Section II Indications for Use Statement Indications for Use 510(k) Number (if known): ___K142888___ Device Name: _Fingertip Pulse Oximeter MD300C318T2 Indications for Use: The MD300C318T2 is intended for spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate. It is intended for adult, adolescent, child and infant users in hospitals, hospital facilities and home healthcare environments. Prescription Use _¥_____ 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 Section III 510(k) Summary This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92. There is no prior submission for the device. 3.1 Submitter Information Manufacturer Name: Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 320,West Building 4, No.83 FuXing Road Beijing 100039, 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 China 100041 Phone: +86-10-88798300 Ext 6020 Fax:215-4052545 Email: cc@choicemmed.com Date prepared：Nov.06, 2014 3.2 Proposed Device Information Device Common Name: Pulse Oximeter Device Trade/Proprietary Name: Fingertip Pulse Oximeter Model: MD300C318T2 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA Class: Ⅱ Panel: Anesthesiology 3.3
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.
- K092620 MD300C318 FINGERTIP PULSE OXIMETER (Beijing Choice Electronic Technology)
Later records that cite K142888
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.