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FDA 510(k)

UNITRON MODEL SOUND F/X II

K-Number: K954516 · 1995-10-07

ApplicantUnitron Industries, Inc.
Decision Date1995-10-07
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

UNITRON MODEL SOUND F/X II 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 1995-10-07 under 510(k) number K954516. 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 SOUND F/X II?

UNITRON MODEL SOUND F/X II is a medical device that received FDA 510(k) clearance on 1995-10-07. The listed applicant is Unitron Industries, Inc.. The 510(k) number is K954516.

When did UNITRON MODEL SOUND F/X II receive FDA 510(k) clearance?

UNITRON MODEL SOUND F/X II received FDA 510(k) clearance on 1995-10-07, under 510(k) number K954516.

Who is the listed applicant for UNITRON MODEL SOUND F/X II?

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 SOUND F/X II?

The FDA product code for UNITRON MODEL SOUND F/X II 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.

K974339UNITRON MODEL SOUND F/XD PROGRAMMABLEK974340UNITRON MODEL SOUND F/XP PROGRAMMABLE MINI BTEK974338UNITRON MODEL F/X PROGRAMMABLE (MINI BTE)K970692UNITRON MODEL SOUND F/X CICK970519UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE)K964511UNITRON MODEL SOUND F/XD +4 (SOUND F/XD +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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