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FDA 510(k)

AUDIONICS PB MAX HEARING AID

K-Number: K800269 · 1980-02-26

ApplicantAudionics Corp.
Decision Date1980-02-26
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

AUDIONICS PB MAX HEARING AID is the device name listed in this FDA 510(k) record. The listed applicant is Audionics Corp.. It received FDA 510(k) clearance on 1980-02-26 under 510(k) number K800269. 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 AUDIONICS PB MAX HEARING AID?

AUDIONICS PB MAX HEARING AID is a medical device that received FDA 510(k) clearance on 1980-02-26. The listed applicant is Audionics Corp.. The 510(k) number is K800269.

When did AUDIONICS PB MAX HEARING AID receive FDA 510(k) clearance?

AUDIONICS PB MAX HEARING AID received FDA 510(k) clearance on 1980-02-26, under 510(k) number K800269.

Who is the listed applicant for AUDIONICS PB MAX HEARING AID?

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

What is the FDA product code for AUDIONICS PB MAX HEARING AID?

The FDA product code for AUDIONICS PB MAX HEARING AID is ESD.

Related Clinical Trials

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.

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Other records listing Audionics 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.

K800940AUDIONICS PB MAX HEARING AID

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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