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FDA 510(k)

ADAM MARK II CUSTOM IN-THE-EAR HEARING AID

K-Number: K902570 · 1990-07-09

ApplicantAdams Hearing Aid Center
Decision Date1990-07-09
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ADAM MARK II CUSTOM IN-THE-EAR HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Adams Hearing Aid Center. It received FDA 510(k) clearance on 1990-07-09 under 510(k) number K902570. 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 ADAM MARK II CUSTOM IN-THE-EAR HEARING AID?

ADAM MARK II CUSTOM IN-THE-EAR HEARING AID is a medical device that received FDA 510(k) clearance on 1990-07-09. The listed applicant is Adams Hearing Aid Center. The 510(k) number is K902570.

When did ADAM MARK II CUSTOM IN-THE-EAR HEARING AID receive FDA 510(k) clearance?

ADAM MARK II CUSTOM IN-THE-EAR HEARING AID received FDA 510(k) clearance on 1990-07-09, under 510(k) number K902570.

Who is the listed applicant for ADAM MARK II CUSTOM IN-THE-EAR HEARING AID?

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

What is the FDA product code for ADAM MARK II CUSTOM IN-THE-EAR HEARING AID?

The FDA product code for ADAM MARK II CUSTOM IN-THE-EAR HEARING AID is ESD.

Related Clinical Trials

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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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