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FDA 510(k)

PHONAK SONO-FORTE 332X-AZ

K-Number: K946294 · 1995-01-26

ApplicantPhonak, Inc.
Decision Date1995-01-26
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHONAK SONO-FORTE 332X-AZ is the device name listed in this FDA 510(k) record. The listed applicant is Phonak, Inc.. It received FDA 510(k) clearance on 1995-01-26 under 510(k) number K946294. 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 SONO-FORTE 332X-AZ?

PHONAK SONO-FORTE 332X-AZ is a medical device that received FDA 510(k) clearance on 1995-01-26. The listed applicant is Phonak, Inc.. The 510(k) number is K946294.

When did PHONAK SONO-FORTE 332X-AZ receive FDA 510(k) clearance?

PHONAK SONO-FORTE 332X-AZ received FDA 510(k) clearance on 1995-01-26, under 510(k) number K946294.

Who is the listed applicant for PHONAK SONO-FORTE 332X-AZ?

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 SONO-FORTE 332X-AZ?

The FDA product code for PHONAK SONO-FORTE 332X-AZ 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 E3K972105PHONAK EPICAK972097PHONAK MICROZOOM P 2K964035PHONAK MICROLINK, PERSONAL FM RECEIVERK961653PHONAK SONA P2K961622PHONAK PICONET2 P2 AZ

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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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