FDA 510(k) · Guangdong Biolight Meditech
K112804: FINGERTIP PULSE OXIMETER (Guangdong Biolight Meditech Co., Ltd.)
Guangdong Biolight Meditech Co., Ltd. received FDA 510(k) K112804 for FINGERTIP PULSE OXIMETER, with a decision date of Jan 27, 2012 (substantially equivalent).
Prescription or OTC: Prescription (Rx) parsed from FDA documents (summary PDF: indications text (parsed))
FDA facts
| FDA number | K112804 |
|---|---|
| Pathway | 510(k) |
| Applicant | Guangdong Biolight Meditech Co., Ltd. |
| Device name | FINGERTIP PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Sep 27, 2011 |
| Decision date | Jan 27, 2012 |
| 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
Project #: M0302O1IIAa Section II Indications for Use 510(k) Number: Device Name: Fingertip Pulse Oximeter Indications for Use: The Fingertip Pulse Oximeters M7OA, M7OB, M70C and M7OD, are intended to measure functional arterial oxygen saturation (SpOz) and pulse rate of adult patients in hospital, hospital type facilities as well as in the home care environment. The oximeters are not suitable to monitor patient continuously for long term. (Divi Sion Sign-off) S4 Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: ,V-//2 'Fog ZPRESCRIPTION USE 50 VER-THE-COUNTER USE (Part 21 CER 801 Subpart D) (2I CFRSOI1 SubpartC) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page I ofI
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
No predicate numbers were parsed for this record. The FDA summary, if available, names the predicate.
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.