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FDA 510(k)

ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR

K-Number: K882721 · 1988-09-15

ApplicantHear-O Inc. C/O L.P. Leale & Assoc.
Decision Date1988-09-15
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR is the device name listed in this FDA 510(k) record. The listed applicant is Hear-O Inc. C/O L.P. Leale & Assoc.. It received FDA 510(k) clearance on 1988-09-15 under 510(k) number K882721. 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 ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR?

ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR is a medical device that received FDA 510(k) clearance on 1988-09-15. The listed applicant is Hear-O Inc. C/O L.P. Leale & Assoc.. The 510(k) number is K882721.

When did ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR receive FDA 510(k) clearance?

ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR received FDA 510(k) clearance on 1988-09-15, under 510(k) number K882721.

Who is the listed applicant for ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR?

The FDA 510(k) record lists Hear-O Inc. C/O L.P. Leale & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR?

The FDA product code for ITC-ITE TYPE HEAR AID/HEAR-O-INC MDL FAVORITE EAR 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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