FDA 510(k) · Guangdong Biolight Meditech
K081712: FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 (Guangdong Biolight Meditech Co., Ltd.)
Guangdong Biolight Meditech Co., Ltd. received FDA 510(k) K081712 for FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700, with a decision date of Sep 12, 2008 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K081712 |
|---|---|
| Pathway | 510(k) |
| Applicant | Guangdong Biolight Meditech Co., Ltd. |
| Device name | FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jun 17, 2008 |
| Decision date | Sep 12, 2008 |
| 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
Statement Report No.: A2008-002-050 Indication for Use 510(k) Number (if known): Device Name: M70 Fingertip Pulse Oximeter Indications for Use: The M70 fingertip pulse oximeter is intended to measure functional arterial oxygen saturation (SpO2) and pulse rate of adult 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. Prescription Use 4I 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) _ _ _ _ _
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 K081712
- K151287 Fingertip Pulse Oximeters M70, M70A, M70B, M70C, M70D (Guangdong Biolight Meditech, Jan 6, 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.