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FDA 510(k)

PROFILE IC; PROFILE CLEARVOICE; PROFILE

K-Number: K940100 · 1994-04-01

ApplicantBeltone Electronics Corp.
Decision Date1994-04-01
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

PROFILE IC; PROFILE CLEARVOICE; PROFILE is the device name listed in this FDA 510(k) record. The listed applicant is Beltone Electronics Corp.. It received FDA 510(k) clearance on 1994-04-01 under 510(k) number K940100. 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 PROFILE IC; PROFILE CLEARVOICE; PROFILE?

PROFILE IC; PROFILE CLEARVOICE; PROFILE is a medical device that received FDA 510(k) clearance on 1994-04-01. The listed applicant is Beltone Electronics Corp.. The 510(k) number is K940100.

When did PROFILE IC; PROFILE CLEARVOICE; PROFILE receive FDA 510(k) clearance?

PROFILE IC; PROFILE CLEARVOICE; PROFILE received FDA 510(k) clearance on 1994-04-01, under 510(k) number K940100.

Who is the listed applicant for PROFILE IC; PROFILE CLEARVOICE; PROFILE?

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

What is the FDA product code for PROFILE IC; PROFILE CLEARVOICE; PROFILE?

The FDA product code for PROFILE IC; PROFILE CLEARVOICE; PROFILE is ESD.

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Related Devices (Code: ESD)

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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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