FDA 510(k) · Beijing Choice Electronic Technology
K101577: MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES (Beijing Choice Electronic Technololgy Co., Ltd.)
Beijing Choice Electronic Technololgy Co., Ltd. received FDA 510(k) K101577 for MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES, with a decision date of Dec 2, 2010 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K101577 |
|---|---|
| Pathway | 510(k) |
| Applicant | Beijing Choice Electronic Technololgy Co., Ltd. |
| Device name | MODIFICATION TO:FINGERTIP PULSE OXIMETER, MODEL MD300C SERIES |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jun 7, 2010 |
| Decision date | Dec 2, 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
Form Attachment VII Indication for Use Form 510(k) Number: K101577 Device Name: Fingertip Pulse Oximeter DEC 2 2010 Indications for Use: The Fingertip Pulse Oximeters, MD300C series, are portable, non-invasive devices intended for spot checking of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at home and hospital (including clinical use in internist/surgery, Anesthesia, and intensive care units). Not for continuous monitoring. Prescription Use V AN/O Over-The-Counter Use ___ (Part 21 CFR 801 Subpart D) AN/R(21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluatidn (ODE) Page Iof 1 Divisionl ol AneshBSI0§V, General Hospital lntectOfl Control, Dental Devices 510 (k)Number: /0/ §
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.