FDA 510(k) · Contec Medical System
K082641: FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL (Contec Medical System Co., Ltd.)
Contec Medical System Co., Ltd. received FDA 510(k) K082641 for FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL, with a decision date of Nov 10, 2008 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K082641 |
|---|---|
| Pathway | 510(k) |
| Applicant | Contec Medical System Co., Ltd. |
| Device name | FINGERTIP PULSE OXIMETER, MODELS CMS-50D, CMS-50L, CMS-50DL |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Sep 11, 2008 |
| Decision date | Nov 10, 2008 |
| 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
Form Report SN: A2008-026-031 Exhibit A Indication for Use Form 510(k) Number: Device Name: Fingertip Pulse Oximeter (CMS-50D, CMS-50L and CMS-50DL) Indications for Use: The Fingertip Pulse Oximeter is a non-invasive device intended for the spot-check of oxygen saturation of arterial hemoglobin (SpO 2) and the pulse rate of adult and pediatric patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care ect.). This device is not intended for continuous monitoring. 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) 'w 1)2~ ~ -Page IL of 1 (DvisiOR-ign-Of Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: _:_ _ _ __..
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.
- K073454 FINGERTIP PULSE OXIMETER, MODEL CMS-50C (Contec Medical System)
Later records that cite K082641
- K140582 FINGERTIP PULSE OXIMETER (Shenzhen Jumper Medical Equipment, Aug 28, 2014, 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.