FDA 510(k) · Beijing Choice Electronic Technology
K093757: MD300C1 FINGERTIP PULSE OXIMETER (Beijing Choice Electronic Technololgy Co., Ltd.)
Beijing Choice Electronic Technololgy Co., Ltd. received FDA 510(k) K093757 for MD300C1 FINGERTIP PULSE OXIMETER, with a decision date of Mar 3, 2010 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K093757 |
|---|---|
| Pathway | 510(k) |
| Applicant | Beijing Choice Electronic Technololgy Co., Ltd. |
| Device name | MD300C1 FINGERTIP PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Dec 7, 2009 |
| Decision date | Mar 3, 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
510(k) Number (if known): PEending, Device Name: MD300CI Fingertip Pulse Oximeter Indications for Use: MD300CI Fingertip Pulse Oxirneter 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 I/ADO Over-The-Counter Use ___ (Part 21 CFR 801 Subpart D) (1CR81SbatC (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Dvso Ign-Ott) DMivision Of Anesthesiology, General Hospital Infection Control, Dental Devices
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.
- K070371 FINGERTIP PULSE OXIMETER MD300C (Beijing Choice Electronic Technology)
Later records that cite K093757
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.