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FDA 510(k)

HEARING AID(ALL IN THE EAR(ALL IN THE CANAL

K-Number: K852052 · 1985-08-16

ApplicantPenn-Tech Laboratories
Decision Date1985-08-16
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent for Some Indications

Device Summary

HEARING AID(ALL IN THE EAR(ALL IN THE CANAL is the device name listed in this FDA 510(k) record. The listed applicant is Penn-Tech Laboratories. It received FDA 510(k) clearance on 1985-08-16 under 510(k) number K852052. The device is classified under product code ESD. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the HEARING AID(ALL IN THE EAR(ALL IN THE CANAL?

HEARING AID(ALL IN THE EAR(ALL IN THE CANAL is a medical device that received FDA 510(k) clearance on 1985-08-16. The listed applicant is Penn-Tech Laboratories. The 510(k) number is K852052.

When did HEARING AID(ALL IN THE EAR(ALL IN THE CANAL receive FDA 510(k) clearance?

HEARING AID(ALL IN THE EAR(ALL IN THE CANAL received FDA 510(k) clearance on 1985-08-16, under 510(k) number K852052.

Who is the listed applicant for HEARING AID(ALL IN THE EAR(ALL IN THE CANAL?

The FDA 510(k) record lists Penn-Tech Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HEARING AID(ALL IN THE EAR(ALL IN THE CANAL?

The FDA product code for HEARING AID(ALL IN THE EAR(ALL IN THE CANAL is ESD.

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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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