FDA 510(k) · Beijing Choice Electronic Technology
K081125: WRIST PULSE OXIMETER MD300W (Beijing Choice Electronic Technololgy Co., Ltd.)
Beijing Choice Electronic Technololgy Co., Ltd. received FDA 510(k) K081125 for WRIST PULSE OXIMETER MD300W, with a decision date of Jul 2, 2008 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K081125 |
|---|---|
| Pathway | 510(k) |
| Applicant | Beijing Choice Electronic Technololgy Co., Ltd. |
| Device name | WRIST PULSE OXIMETER MD300W |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Apr 21, 2008 |
| Decision date | Jul 2, 2008 |
| 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
The MD300W wrist oximeter is a portable non-invasive, spot-check, oxygen saturation of arterial hemoglobin (SpO 2) 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 A 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) (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices Page I of l _51 0(k) Number: 1(,b q1tz•
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.
- K072825 FINGERTIP PULSE OXIMETER, MODEL MD300I (Beijing Choice Electronic Technology)
Later records that cite K081125
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.