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Pulse Oximeter Model AB-F1/AH-S1/AH-M1

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K111617Ref AH-MX

by Acare Technology Co., Ltd.

Identity

Trade Name
Pulse Oximeter EUDAMED
Device Name
Pulse Oximeter EUDAMED
Model / Reference
AH-MX EUDAMED

Identifiers

Primary DI / UDI-DI
04719872740049 EUDAMED
Basic UDI-DI
B-04719872740049 EUDAMED
510(k) Number
K111617 FDA 510(k)
FDA Product Code
DQA FDA 510(k)
EMDN Code
Z1203020408 PULSE OXIMETERS EUDAMED
Models / Variants
Ab-F1 FDA 510(k)EUDAMED
Ah-S1 FDA 510(k)EUDAMED
Ah-M1 FDA 510(k)EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.2700 FDA 510(k)
Regulation Number
870.2700 FDA 510(k)
Market of Registration
Spain EUDAMED
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

This device is a pulse oximeter, a non-invasive monitor used to measure oxygen saturation levels in arterial blood and pulse rate. It operates by transmitting light through a patient’s finger, earlobe, or other perfused tissue to detect hemoglobin oxygenation, providing real-time physiological data for clinical assessment.

The Pulse Oximeter Model AB-F1/AH-S1/AH-M1 is designed for single-use or reusable applications in clinical settings, including hospitals and outpatient care. Supplied sterile or non-sterile depending on model variant, it adheres to FDA 510(k) clearance (K111617) and MDD compliance. Sizes and configurations are specified by the model variants AB-F1, AH-S1, and AH-M1, with no MRI safety restrictions stated.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Acare Technology Co., Ltd.

Sources (2)

  • FDA 510(k) K111617 24 fields · synced Sep 18, 2026
  • EUDAMED 96061fdc-2ec2-4f07-9568-7b4d3dc17363 61 fields · synced Jul 10, 2026