FDA 510(k) · Beijing Choice Electronic Technology
K092652: FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA (Beijing Choice Electronic Technololgy Co., Ltd.)
Beijing Choice Electronic Technololgy Co., Ltd. received FDA 510(k) K092652 for FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA, with a decision date of Jan 8, 2010 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K092652 |
|---|---|
| Pathway | 510(k) |
| Applicant | Beijing Choice Electronic Technololgy Co., Ltd. |
| Device name | FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Aug 28, 2009 |
| Decision date | Jan 8, 2010 |
| Decision | Substantially Equivalent (SESE) |
| 510(k) type | Special |
Source: openFDA device 510(k) data, data through Oct 26, 2026.
Indications for use parsed from FDA documents
The MD300CA Fingertip Pulse Oximeter is a portable Oximeter intended for spot-check use to non-invasively measure oxvuen saturation of arterial hemoglobin (SpO2 ) and pulse rate of adult and pediatric patient at home and hospital settings (including clinical use in internist/ surgery, Anesthesia, intensive care and etc). Not for continuouIsly monitoring. Prescription Use /AND/OR Over-The-Counter Use ____ (Part 21 CFRSOI1 Subpart D) (21 CFRSOI1 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-Oft) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page I ofI 510(k) Number:kQj -2C5 .
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
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
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.