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FDA 510(k)

PHONAK ITE 8000, 7000, 6000 ITE HEARING AID

K-Number: K900675 · 1990-05-23

ApplicantPhonak, Inc.
Decision Date1990-05-23
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PHONAK ITE 8000, 7000, 6000 ITE HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Phonak, Inc.. It received FDA 510(k) clearance on 1990-05-23 under 510(k) number K900675. 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 ITE 8000, 7000, 6000 ITE HEARING AID?

PHONAK ITE 8000, 7000, 6000 ITE HEARING AID is a medical device that received FDA 510(k) clearance on 1990-05-23. The listed applicant is Phonak, Inc.. The 510(k) number is K900675.

When did PHONAK ITE 8000, 7000, 6000 ITE HEARING AID receive FDA 510(k) clearance?

PHONAK ITE 8000, 7000, 6000 ITE HEARING AID received FDA 510(k) clearance on 1990-05-23, under 510(k) number K900675.

Who is the listed applicant for PHONAK ITE 8000, 7000, 6000 ITE HEARING AID?

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 ITE 8000, 7000, 6000 ITE HEARING AID?

The FDA product code for PHONAK ITE 8000, 7000, 6000 ITE HEARING AID 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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