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FDA 510(k)

PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1

K-Number: K111617 · 2011-12-22

ApplicantAcare Technology Co., Ltd.
Decision Date2011-12-22
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 is the device name listed in this FDA 510(k) record. The listed applicant is Acare Technology Co., Ltd.. It received FDA 510(k) clearance on 2011-12-22 under 510(k) number K111617. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1?

PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 is a medical device that received FDA 510(k) clearance on 2011-12-22. The listed applicant is Acare Technology Co., Ltd.. The 510(k) number is K111617.

When did PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 receive FDA 510(k) clearance?

PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 received FDA 510(k) clearance on 2011-12-22, under 510(k) number K111617.

Who is the listed applicant for PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1?

The FDA 510(k) record lists Acare Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1?

The FDA product code for PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1 is DQA.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Acare Technology Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182950Acare Suction Unit

Related Devices (Code: DQA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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