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FDA 510(k)

OVATION HDP

K-Number: K972373 · 1997-07-29

ApplicantOrsonique, Inc.
Decision Date1997-07-29
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

OVATION HDP is the device name listed in this FDA 510(k) record. The listed applicant is Orsonique, Inc.. It received FDA 510(k) clearance on 1997-07-29 under 510(k) number K972373. 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 HDP?

OVATION HDP is a medical device that received FDA 510(k) clearance on 1997-07-29. The listed applicant is Orsonique, Inc.. The 510(k) number is K972373.

When did OVATION HDP receive FDA 510(k) clearance?

OVATION HDP received FDA 510(k) clearance on 1997-07-29, under 510(k) number K972373.

Who is the listed applicant for OVATION HDP?

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 HDP?

The FDA product code for OVATION HDP is ESD.

Related Clinical Trials

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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.

K963819OVATION ASPK963818OVATION AGC-2K963821OVATION AGC-1K963820OVATION 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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