FDA 510(k) · Guangdong Biolight Meditech
K151287: Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D (Guangdong Biolight Meditech Co., Ltd.)
Guangdong Biolight Meditech Co., Ltd. received FDA 510(k) K151287 for Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D, with a decision date of Jan 6, 2016 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K151287 |
|---|---|
| Pathway | 510(k) |
| Applicant | Guangdong Biolight Meditech Co., Ltd. |
| Device name | Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | May 14, 2015 |
| Decision date | Jan 6, 2016 |
| 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
The Fingertip Pulse Oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult, child and adolescent patients in hospital, hospital type facilities, as well as in the home care environment. The oximeter is not suitable to monitor patient continuously for long term.
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.
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.