FDA 510(k) · Beijing Choice Electronic Technology
K070371: FINGERTIP PULSE OXIMETER MD300C (Beijing Choice Electronic Technololgy Co., Ltd.)
Beijing Choice Electronic Technololgy Co., Ltd. received FDA 510(k) K070371 for FINGERTIP PULSE OXIMETER MD300C, with a decision date of Aug 13, 2007 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K070371 |
|---|---|
| Pathway | 510(k) |
| Applicant | Beijing Choice Electronic Technololgy Co., Ltd. |
| Device name | FINGERTIP PULSE OXIMETER MD300C |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Feb 8, 2007 |
| Decision date | Aug 13, 2007 |
| 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
Report No.: A20060123 Indications for Use 510(k) Number: Pending Device Name: Fingertip Pulse Oximeter MD300C Indications for Use: Fingertip Pulse Oximeter MD300C is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care and etc). Not for continuously monitoring. Prescription Use 4 Over-The-Counter Use (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) (Division Sign-Off) (&c--'½ 6,- Page 1, of 1 Division of Anesthesiology, General HospitalPae1o Infection Control, Dental Devices 510(k) Number: KaCO'13 (
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.
Later records that cite K070371
- K180174 Belun Ring (Belun, May 29, 2018, DQA)
- K140682 FINGERTIP PULSE OXIMETER (Beijing Choice Electronic Technology, Jul 17, 2014, DQA)
- K131047 FINGERTIP PULSE OXIMETER (Beijing Choice Electronic Technology, Oct 16, 2013, DQA)
- K123871 FINGERTIP PULSE OXIMETER (Beijing Choice Electronic Technology, May 10, 2013, DQA)
- K093757 MD300C1 FINGERTIP PULSE OXIMETER (Beijing Choice Electronic Technology, Mar 3, 2010, DQA)
- K081712 FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 (Guangdong Biolight Meditech, Sep 12, 2008, DQA)
- K073454 FINGERTIP PULSE OXIMETER, MODEL CMS-50C (Contec Medical System, May 5, 2008, DQA)
- K072825 FINGERTIP PULSE OXIMETER, MODEL MD300I (Beijing Choice Electronic Technology, Jan 14, 2008, DQA)
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.