FDA 510(k) · Beijing Choice Electronic Technology
K172366: Wrist Pulse Oximeter (Beijing Choice Electronic Technology Co., Ltd.)
Beijing Choice Electronic Technology Co., Ltd. received FDA 510(k) K172366 for Wrist Pulse Oximeter, with a decision date of Mar 16, 2018 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K172366 |
|---|---|
| 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 | Aug 4, 2017 |
| Decision date | Mar 16, 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
MD300W512 / MD300W314/ MD300W314B4 is a wrist pulse oximeter indicated for use in measuring, displaying, storing and transmitting functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate for adult, adolescent, child and infant patients. It is intended for spot-check and / or data collection, recording and transmitting. It can be used in sleep labs, long-term care, hospitals and home use. 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) Section II-1 Premarket Notification 510(k) Submission—Section III 510(k) Summary Section III 510(k) Summary This summary of 510(k) is being submitted in accordance with the requirements of 21 CFR 807.92. There is no prior submission for the device. 3.1 Submitter Information Manufacturer Name: Establishment Registration Number: 3005569927 Beijing Choice Electronic Technology Co., Ltd. Room 4104,No.A12 Yuquan Road Haidian District 100143 Beijing, P.R.China Contact Person: Mr. Lei Chen Beijing Choice Electronic Technology Co., Ltd. North Building 3F, No. 9 Shuangyuan Road, Badachu Hi-tech Zone, Shijingshan District Beijing China 100041 Phone: +86-10-88798300 Ext 6020 Fax:215-4052545 Email: cc@choicemmed.com Date prepared：February 12, 2018 3.2 Proposed Device Information Device Common Name: Wrist Pulse Oximeter Device Trade/Proprietary Name: Pulse Oximeter Model: MD300W512/MD300W314/MD300W314B4 Classification Name: Oximeter Regulation Number: 870.2700 Product Code: DQA Class: Ⅱ Panel: Anesthesiology III-1 Premarket Notification 510(k) Submission—Section III 510(k) Summary 3.3
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 K172366
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.