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FDA 510(k)

OVATION AGC-1

K-Number: K963821 · 1996-10-28

ApplicantOrsonique, Inc.
Decision Date1996-10-28
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OVATION AGC-1 is the device name listed in this FDA 510(k) record. The listed applicant is Orsonique, Inc.. It received FDA 510(k) clearance on 1996-10-28 under 510(k) number K963821. 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 OVATION AGC-1?

OVATION AGC-1 is a medical device that received FDA 510(k) clearance on 1996-10-28. The listed applicant is Orsonique, Inc.. The 510(k) number is K963821.

When did OVATION AGC-1 receive FDA 510(k) clearance?

OVATION AGC-1 received FDA 510(k) clearance on 1996-10-28, under 510(k) number K963821.

Who is the listed applicant for OVATION AGC-1?

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

What is the FDA product code for OVATION AGC-1?

The FDA product code for OVATION AGC-1 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 Orsonique, 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.

K972373OVATION HDPK963819OVATION ASPK963818OVATION AGC-2K963820OVATION LINEARK963822OVATION AGC-3

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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