FDA 510(k) · Beijing Choice Electronic Technology
K092620: MD300C318 FINGERTIP PULSE OXIMETER (Beijing Choice Electronic Technololgy Co., Ltd.)
Beijing Choice Electronic Technololgy Co., Ltd. received FDA 510(k) K092620 for MD300C318 FINGERTIP PULSE OXIMETER, with a decision date of Dec 4, 2009 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K092620 |
|---|---|
| Pathway | 510(k) |
| Applicant | Beijing Choice Electronic Technololgy Co., Ltd. |
| Device name | MD300C318 FINGERTIP PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Aug 26, 2009 |
| Decision date | Dec 4, 2009 |
| 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
statement Report No.: TE200903 12 Indication for Use 5 10(k) Number (if known): -K092620 Device Name: MD300C3 18 Fingertip Pulse Oxirneter Indications for Use: The MD300C318 Fingertip Pulse Oximneter is intended for continuous use or spot checking in measuring and displaying functional arterial oxygen saturation (SpO2) and pulse rate of patients in hospitals and home care. It is intended for adult and pediatric patients on finger between 0.3-1.0 inch (0.8 -2.5 cm) thick. Prescription Use I/ADO Over-The-Counter Use (Part 21 CFR 801I 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) Divison enerl ofAneshesioogy, HositalPage 1 of I__ 5la(k) NUMber. -Z o cC-Oj 11-2
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.
Later records that cite K092620
- K142888 Fingertip Pulse Oximeter (Beijing Choice Electronic Technology, Feb 20, 2015, 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.