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FDA 510(k)

AHS OMEGA K-AMP

K-Number: K963875 · 1996-11-27

ApplicantAuthorized Hearing Systems, Inc.
Decision Date1996-11-27
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AHS OMEGA K-AMP 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 1996-11-27 under 510(k) number K963875. 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 K-AMP?

AHS OMEGA K-AMP is a medical device that received FDA 510(k) clearance on 1996-11-27. The listed applicant is Authorized Hearing Systems, Inc.. The 510(k) number is K963875.

When did AHS OMEGA K-AMP receive FDA 510(k) clearance?

AHS OMEGA K-AMP received FDA 510(k) clearance on 1996-11-27, under 510(k) number K963875.

Who is the listed applicant for AHS OMEGA K-AMP?

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 K-AMP?

The FDA product code for AHS OMEGA K-AMP 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-79PK970057AHS OMEGA SPK963878AHS OMEGA HFK963877AHS OMEGA CONCEPTK963879AHS DELTA 22K963874AHS OMEGA AGC

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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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