FDA 510(k) · Beijing Choice Electronic Technology
K230587: Wrist Pulse Oximeter (Beijing Choice Electronic Technology Co., Ltd.)
Beijing Choice Electronic Technology Co., Ltd. received FDA 510(k) K230587 for Wrist Pulse Oximeter, with a decision date of Nov 30, 2023 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K230587 |
|---|---|
| Pathway | 510(k) |
| Applicant | Beijing Choice Electronic Technology Co., Ltd. |
| Device name | Wrist Pulse Oximeter |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Mar 2, 2023 |
| Decision date | Nov 30, 2023 |
| 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
The MD300W628 Wrist Pulse Oximeter is a portable, non-invasive device intended to measure, display, store and transfer functional oxygen saturation of arterial hemoglobin (%SpO2) and pulse rate (PR) of adult, adolescent and child in hospitals, clinics, long-term care, and home use. The device intended for spot-checking and can be reused, not intended for continuous monitoring, use during motion or use with low perfusion.
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.
- K172366 Wrist 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 Wrist PPG. These are heuristics, not FDA fields.