# K111617: Pulse Oximeter Model AB-F1/AH-S1/AH-M1

- Pathway: 510(k) (Traditional)
- Applicant: Acare Technology Co., Ltd.
- Decided: Dec 22, 2011 after 195 days
- Product code: DQA (Oximeter)
- Device class: 2
- Regulation: 21 CFR 870.2700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Finger Type Pulse Oximeter, AB-F I is indicated for spot checking of functional arterial oxygen saturation (SpO 2 ) and pulse rate in hospital, hospital type facilities as well as in the home care environment. It is intended for adult patients use. Handheld Pulse Oximeter, AH-S I is indicated for spot checking of functional arterial oxygen saturation (SpO 2 ) and pulse rate in hospital, hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use. Handhield Pulse Oximeter, AH-M I is indicated for spot checking of functional arterial oxygen saturation (SpO2) and pulse rate in hospital, hospital type facilities as well as in the home care environment. It is intended for adult, pediatric and neonatal patients use.

Source page: https://510kreport.com/device/K111617
Methodology: https://510kreport.com/methodology