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FDA 510(k)

PHONAK EPICA

K-Number: K972105 · 1997-08-01

ApplicantPhonak, Inc.
Decision Date1997-08-01
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHONAK EPICA is the device name listed in this FDA 510(k) record. The listed applicant is Phonak, Inc.. It received FDA 510(k) clearance on 1997-08-01 under 510(k) number K972105. 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 PHONAK EPICA?

PHONAK EPICA is a medical device that received FDA 510(k) clearance on 1997-08-01. The listed applicant is Phonak, Inc.. The 510(k) number is K972105.

When did PHONAK EPICA receive FDA 510(k) clearance?

PHONAK EPICA received FDA 510(k) clearance on 1997-08-01, under 510(k) number K972105.

Who is the listed applicant for PHONAK EPICA?

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

What is the FDA product code for PHONAK EPICA?

The FDA product code for PHONAK EPICA is ESD.

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Other records listing Phonak, 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.

K972106PHONAK NOVO FORTE E3K972097PHONAK MICROZOOM P 2K964035PHONAK MICROLINK, PERSONAL FM RECEIVERK961653PHONAK SONA P2K961622PHONAK PICONET2 P2 AZK953921PHONAK 9900 CIC

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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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