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FDA 510(k)

AUDIFON H20 PC/AUDIFON H32 PP

K-Number: K972552 · 1997-07-30

ApplicantTrutone
Decision Date1997-07-30
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIFON H20 PC/AUDIFON H32 PP is the device name listed in this FDA 510(k) record. The listed applicant is Trutone. It received FDA 510(k) clearance on 1997-07-30 under 510(k) number K972552. 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 AUDIFON H20 PC/AUDIFON H32 PP?

AUDIFON H20 PC/AUDIFON H32 PP is a medical device that received FDA 510(k) clearance on 1997-07-30. The listed applicant is Trutone. The 510(k) number is K972552.

When did AUDIFON H20 PC/AUDIFON H32 PP receive FDA 510(k) clearance?

AUDIFON H20 PC/AUDIFON H32 PP received FDA 510(k) clearance on 1997-07-30, under 510(k) number K972552.

Who is the listed applicant for AUDIFON H20 PC/AUDIFON H32 PP?

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

What is the FDA product code for AUDIFON H20 PC/AUDIFON H32 PP?

The FDA product code for AUDIFON H20 PC/AUDIFON H32 PP 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 Trutone 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.

K973377SIBELMED AC50DK972550AUDIFON H24 AGC/AUDIFON H25 AGC/AUDIFON H30 AGCK972542JAZZ PP AGC-O, JAZZ PPK972543TWIST PPAGC-1, TWIST PP

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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