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FDA 510(k)

PHONAK 9100 SC-AF ITE HEARING INSTRUMENT

K-Number: K911211 · 1991-04-17

ApplicantPhonak, Inc.
Decision Date1991-04-17
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHONAK 9100 SC-AF ITE HEARING INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Phonak, Inc.. It received FDA 510(k) clearance on 1991-04-17 under 510(k) number K911211. 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 9100 SC-AF ITE HEARING INSTRUMENT?

PHONAK 9100 SC-AF ITE HEARING INSTRUMENT is a medical device that received FDA 510(k) clearance on 1991-04-17. The listed applicant is Phonak, Inc.. The 510(k) number is K911211.

When did PHONAK 9100 SC-AF ITE HEARING INSTRUMENT receive FDA 510(k) clearance?

PHONAK 9100 SC-AF ITE HEARING INSTRUMENT received FDA 510(k) clearance on 1991-04-17, under 510(k) number K911211.

Who is the listed applicant for PHONAK 9100 SC-AF ITE HEARING INSTRUMENT?

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 9100 SC-AF ITE HEARING INSTRUMENT?

The FDA product code for PHONAK 9100 SC-AF ITE HEARING INSTRUMENT 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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