FDA 510(k) · Andon Health
K121697: FINGERTIP PULSE OXIMETER (Andon Health Co, Ltd.)
Andon Health Co, Ltd. received FDA 510(k) K121697 for FINGERTIP PULSE OXIMETER, with a decision date of Oct 15, 2012 (substantially equivalent).
Prescription or OTC: Unknown (no FDA document we parsed states it).
FDA facts
| FDA number | K121697 |
|---|---|
| Pathway | 510(k) |
| Applicant | Andon Health Co, Ltd. |
| Device name | FINGERTIP PULSE OXIMETER |
| Product code | DQA: Oximeter |
| Regulation (21 CFR) | 870.2700 |
| Device class | Class 2 |
| Date received | Jun 7, 2012 |
| Decision date | Oct 15, 2012 |
| 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
510k) N um ber: K1 21697 Device name: APO-8284 Fingertip Pulse Oximeter Indications for use: The APO-8284 Fingertip Pulse Oximeter is a non-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). The APO-8284 Fingertip Pulse oximeter is not intended for continuous monitoring. Prescription use I/ AND/OR Over-The-Counter Use ____ Part 21 CER 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-COUNTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) U4 Page Ilof I (Division Sign-ff Divsion of Anesthesiology, General Hospital infection Control, Dental Devices 510(k) Number:_ tLJ-2( (717 .
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.
- K093757 MD300C1 FINGERTIP PULSE OXIMETER (Beijing Choice Electronic Technology)
Later records that cite K121697
- K131111 IHEALTH FINGERTIP PULSE OXIMETER (Andon Health, Sep 11, 2013, 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.