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FDA 510(k)

AHS OMEGA SP

K-Number: K970057 · 1997-02-26

ApplicantAuthorized Hearing Systems, Inc.
Decision Date1997-02-26
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AHS OMEGA SP is the device name listed in this FDA 510(k) record. The listed applicant is Authorized Hearing Systems, Inc.. It received FDA 510(k) clearance on 1997-02-26 under 510(k) number K970057. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AHS OMEGA SP?

AHS OMEGA SP is a medical device that received FDA 510(k) clearance on 1997-02-26. The listed applicant is Authorized Hearing Systems, Inc.. The 510(k) number is K970057.

When did AHS OMEGA SP receive FDA 510(k) clearance?

AHS OMEGA SP received FDA 510(k) clearance on 1997-02-26, under 510(k) number K970057.

Who is the listed applicant for AHS OMEGA SP?

The FDA 510(k) record lists Authorized Hearing Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AHS OMEGA SP?

The FDA product code for AHS OMEGA SP is ESD.

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 Authorized Hearing Systems, Inc. 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.

K971693RIONET HB-79PK963877AHS OMEGA CONCEPTK963878AHS OMEGA HFK963875AHS OMEGA K-AMPK963873AHS OMEGA DEQK963879AHS DELTA 22

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Related Devices (Code: ESD)

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.

K232999Lyric4 Hearing AidSonova AGK130790LYRIC2Phonak, LLCK081136LYRIC HEARING AIDInsound Medical, Inc.K021867INSOUND XT SERIES HEARING AIDInsound Medical, Inc.K003558TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)Siemens Hearing Instruments, Inc.K984518SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELLSonic Innovations, Inc.

Official Source

View on FDA Database →

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

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