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FDA 510(k)

ITE HEARING AID PARKER/TECHNITONE, MODEL PA

K-Number: K884997 · 1989-03-29

ApplicantHearing Enhancement Center, Inc.
Decision Date1989-03-29
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ITE HEARING AID PARKER/TECHNITONE, MODEL PA is the device name listed in this FDA 510(k) record. The listed applicant is Hearing Enhancement Center, Inc.. It received FDA 510(k) clearance on 1989-03-29 under 510(k) number K884997. 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 ITE HEARING AID PARKER/TECHNITONE, MODEL PA?

ITE HEARING AID PARKER/TECHNITONE, MODEL PA is a medical device that received FDA 510(k) clearance on 1989-03-29. The listed applicant is Hearing Enhancement Center, Inc.. The 510(k) number is K884997.

When did ITE HEARING AID PARKER/TECHNITONE, MODEL PA receive FDA 510(k) clearance?

ITE HEARING AID PARKER/TECHNITONE, MODEL PA received FDA 510(k) clearance on 1989-03-29, under 510(k) number K884997.

Who is the listed applicant for ITE HEARING AID PARKER/TECHNITONE, MODEL PA?

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

What is the FDA product code for ITE HEARING AID PARKER/TECHNITONE, MODEL PA?

The FDA product code for ITE HEARING AID PARKER/TECHNITONE, MODEL PA 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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