FDA 510(k) · Beijing Choice Electronic Technology
K122046: WRIST PULSE OXIMETER (Beijing Choice Electronic Technololgy Co., Ltd.)
Beijing Choice Electronic Technololgy Co., Ltd. received FDA 510(k) K122046 for WRIST PULSE OXIMETER, with a decision date of Feb 4, 2013 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K122046 |
|---|---|
| Pathway | 510(k) |
| Applicant | Beijing Choice Electronic Technololgy Co., Ltd. |
| Device name | WRIST PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jul 12, 2012 |
| Decision date | Feb 4, 2013 |
| 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
Exhibit A Indications for Use 5 10(k) Number (if known): K122046 Device Name: Wrist Pulse Oximeter Indications for Use: The MD300W4 wrist pulse oximeter is a portable non-invasive device intended for spot checking ,data collection and recording of arterial oxygen saturation (SpO2) and pulse rate of adult and pediatric patient at home and hospital( including clinical use in intemnist/ surgery, Anesthesia, intensive care and etc). Prescription Use .4AND/OR Over-The-Counter Use ___ (Part 21 CFR 801 Subpart D) (21 CFR 801 SubpartC) (PLEASE DO NOT WRITE BELOW THIS -LINE-CONTIN UE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRI-, Office of Device Evaluation (ODE) Lester W. Schultheis Jr 2013.02.01 15:3343 -05'00'Pa lfI (Division Sign-Off) Division of Anesthesiology. General Hospitl Infection Control, Dental Devices 510(k) Number ~ 10/ A-1
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.
- K081125 WRIST PULSE OXIMETER MD300W (Beijing Choice Electronic Technology)
Later records that cite K122046
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.