FDA 510(k) · Beijing Choice Electronic Technology
K131047: FINGERTIP PULSE OXIMETER (Beijing Choice Electronic Technololgy Co., Ltd.)
Beijing Choice Electronic Technololgy Co., Ltd. received FDA 510(k) K131047 for FINGERTIP PULSE OXIMETER, with a decision date of Oct 16, 2013 (substantially equivalent).
Prescription or OTC: OTC parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K131047 |
|---|---|
| Pathway | 510(k) |
| Applicant | Beijing Choice Electronic Technololgy Co., Ltd. |
| Device name | FINGERTIP PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Apr 15, 2013 |
| Decision date | Oct 16, 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
Section 2 Indications for Use Statement Indications for Use 510(k) Number (if known): K(131047 Device Name: Fingertip Pukse Oximeter MD300CB3 Indications for Use: The Fingertip Pulse Oximeter MD300CB3 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent, child and infant patient in hospital. Prscipio UeAND/ORk Over-The-Counter Use _ __ (Part 21 CFR 801 Subpart D) (21 CER 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Nayan i. Patel -5 Page I of 1 201 3.10.15 13:01:56 -04'00' 2-1
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.
- K070371 FINGERTIP PULSE OXIMETER MD300C (Beijing Choice Electronic Technology)
Later records that cite K131047
- K160268 Fingertip Pulse Oximeter MD300CG11/MD300CG51 (Beijing Choice Electronic Technology, Oct 14, 2016, DQA)
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.