FDA 510(k) · Beijing Choice Electronic Technology
K181503: Fingertip Pulse Oximeter (Beijing Choice Electronic Technology Co., Ltd.)
Beijing Choice Electronic Technology Co., Ltd. received FDA 510(k) K181503 for Fingertip Pulse Oximeter, with a decision date of Oct 11, 2018 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K181503 |
|---|---|
| Pathway | 510(k) |
| Applicant | Beijing Choice Electronic Technology Co., Ltd. |
| Device name | Fingertip Pulse Oximeter |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jun 7, 2018 |
| Decision date | Oct 11, 2018 |
| 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
Section II Indications for Use Statement Indications for Use 510(k) Number (if known): ______ K181503 Device Name: _Fingertip Pulse Oximeter MD300CI218 Indications for Use: The Fingertip Pulse Oximeter MD300CI218 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients in hospitals, hospital-type facilities and homecare environment. Prescription Use _√_____ Over-The-Counter Use _____ AND/OR (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) II-1 K181503
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.
- K142888 Fingertip Pulse Oximeter (Beijing Choice Electronic Technology)
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.