FDA 510(k) · Andon Health
K131111: IHEALTH FINGERTIP PULSE OXIMETER (Andon Health Co, Ltd.)
Andon Health Co, Ltd. received FDA 510(k) K131111 for IHEALTH FINGERTIP PULSE OXIMETER, with a decision date of Sep 11, 2013 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K131111 |
|---|---|
| Pathway | 510(k) |
| Applicant | Andon Health Co, Ltd. |
| Device name | IHEALTH FINGERTIP PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Apr 19, 2013 |
| Decision date | Sep 11, 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
6101k) Number: K131111 Device name: iHealth PO3M FinpiertiD Pulse Oximeter Indications for use: The PO3M Wireless Pulse Oximeter is a nan-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate. The portable fingertip device is indicated for adult patients in home and hospital environments (including clinical use in internist/surgery, anesthesia, intensive care, etc). Prescription use ./ AND/OR Over-The-Counter Use _____ Part21 CFR 80 1Subpart D) (21 CFR807 SubpartC) (PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Lester W.Schultheis Jr 2013.09.10 15:38:01 -04'00' (Division Sign-Off)PaeIoI Division of Anesthesiology, General Hospital Pgeo I Respiratory, Infection Control and Dental Devices 510(k) Number: _K131111 4.
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.
- K121697 FINGERTIP PULSE OXIMETER (Andon Health)
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.