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FDA 510(k)

UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)

K-Number: K974338 · 1997-12-12

ApplicantUnitron Industries, Inc.
Decision Date1997-12-12
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) is the device name listed in this FDA 510(k) record. The listed applicant is Unitron Industries, Inc.. It received FDA 510(k) clearance on 1997-12-12 under 510(k) number K974338. 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 UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)?

UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) is a medical device that received FDA 510(k) clearance on 1997-12-12. The listed applicant is Unitron Industries, Inc.. The 510(k) number is K974338.

When did UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) receive FDA 510(k) clearance?

UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) received FDA 510(k) clearance on 1997-12-12, under 510(k) number K974338.

Who is the listed applicant for UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)?

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

What is the FDA product code for UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)?

The FDA product code for UNITRON MODEL F/X PROGRAMMABLE (MINI BTE) is ESD.

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Other records listing Unitron Industries, 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.

K974340UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTEK974339UNITRON MODEL SOUND F/XD PROGRAMMABLEK970692UNITRON MODEL SOUND F/X CICK970519UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)K964511UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +4)K964503UNITRON MODEL SOUND F/X +4

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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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