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FDA 510(k)

INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA

K-Number: K890525 · 1989-05-19

ApplicantMagnatone Hearing Aid Corp.
Decision Date1989-05-19
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA is the device name listed in this FDA 510(k) record. The listed applicant is Magnatone Hearing Aid Corp.. It received FDA 510(k) clearance on 1989-05-19 under 510(k) number K890525. 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 INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA?

INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA is a medical device that received FDA 510(k) clearance on 1989-05-19. The listed applicant is Magnatone Hearing Aid Corp.. The 510(k) number is K890525.

When did INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA receive FDA 510(k) clearance?

INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA received FDA 510(k) clearance on 1989-05-19, under 510(k) number K890525.

Who is the listed applicant for INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA?

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

What is the FDA product code for INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA?

The FDA product code for INTERTON BTE HEAR AID, SUPRA, SUPREMA, MINETTA is ESD.

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Other records listing Magnatone Hearing Aid Corp. 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.

K973861FUTURA 67M, 68M, MEGAPOWERMP97, INTEGRA 70,71,72,73, SUPRA 51,52, SUPRA 56,57,58,59, SUPREMA 45, 46, 47,48K973665MAGNATONE / STERLING/ ST; MAGNATONE/DB; MAGNATONE/ LIBERTY/ LB; MAGNATONE/ PEARL/PH C.I.C., S.P.I., ONE TOUCH, DESIGNERK944241MAGNATONE MODEL M PREWIRED FACEPLATE HEARING AIDK911183NHS 2044P BODY AID, HEARING AIDK911182NNHS 2050 SERIES (2055W-2054PP) HEARING AIDSK911174NHS 2009SP HEARING AID

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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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