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FDA 510(k)

BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL

K-Number: K901569 · 1990-04-18

ApplicantUnitron Industries, Inc.
Decision Date1990-04-18
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL 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 1990-04-18 under 510(k) number K901569. 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 BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL?

BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL is a medical device that received FDA 510(k) clearance on 1990-04-18. The listed applicant is Unitron Industries, Inc.. The 510(k) number is K901569.

When did BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL receive FDA 510(k) clearance?

BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL received FDA 510(k) clearance on 1990-04-18, under 510(k) number K901569.

Who is the listed applicant for BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL?

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 BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL?

The FDA product code for BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL 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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