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FDA 510(k)

IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL

K-Number: K971807 · 1997-08-07

ApplicantHear-Right, Inc.
Decision Date1997-08-07
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL is the device name listed in this FDA 510(k) record. The listed applicant is Hear-Right, Inc.. It received FDA 510(k) clearance on 1997-08-07 under 510(k) number K971807. 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 IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL?

IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL is a medical device that received FDA 510(k) clearance on 1997-08-07. The listed applicant is Hear-Right, Inc.. The 510(k) number is K971807.

When did IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL receive FDA 510(k) clearance?

IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL received FDA 510(k) clearance on 1997-08-07, under 510(k) number K971807.

Who is the listed applicant for IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL?

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

What is the FDA product code for IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL?

The FDA product code for IN THE EAR, IN THE CANAL, COMPLETELY IN THE CANAL is ESD.

Related Clinical Trials

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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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