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FDA 510(k)

MODEL 28C HEAPING AID

K-Number: K821132 · 1982-05-13

ApplicantTelex Communications, Inc.
Decision Date1982-05-13
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

MODEL 28C HEAPING AID is the device name listed in this FDA 510(k) record. The listed applicant is Telex Communications, Inc.. It received FDA 510(k) clearance on 1982-05-13 under 510(k) number K821132. 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 MODEL 28C HEAPING AID?

MODEL 28C HEAPING AID is a medical device that received FDA 510(k) clearance on 1982-05-13. The listed applicant is Telex Communications, Inc.. The 510(k) number is K821132.

When did MODEL 28C HEAPING AID receive FDA 510(k) clearance?

MODEL 28C HEAPING AID received FDA 510(k) clearance on 1982-05-13, under 510(k) number K821132.

Who is the listed applicant for MODEL 28C HEAPING AID?

The FDA 510(k) record lists Telex Communications, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODEL 28C HEAPING AID?

The FDA product code for MODEL 28C HEAPING AID is ESD.

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Other records listing Telex Communications, 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.

K984243TELEX TINNITUS-COMPANIONK982683TELEX SELECT 1-40 WITH ADAPTIVE COMPRESSIONK964639TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSION-IIK963915TELEX IN-THE-EAR CUSTOM HEARING AID WITH THRESHOLD COMPRESSIONK961143TELEX SELECT 2-40 WITH ADAPTIVE COMPRESSION S2-40K954579TELEX 349 MULTI CROS W/ADAPIVE COMPRESSION

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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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