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FDA 510(k)

TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC

K-Number: K974751 · 1998-03-06

ApplicantGeneral Hearing Instruments, Inc.
Decision Date1998-03-06
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC is the device name listed in this FDA 510(k) record. The listed applicant is General Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1998-03-06 under 510(k) number K974751. 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 TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC?

TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC is a medical device that received FDA 510(k) clearance on 1998-03-06. The listed applicant is General Hearing Instruments, Inc.. The 510(k) number is K974751.

When did TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC receive FDA 510(k) clearance?

TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC received FDA 510(k) clearance on 1998-03-06, under 510(k) number K974751.

Who is the listed applicant for TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC?

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

What is the FDA product code for TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC?

The FDA product code for TRANQUIL TRI-OE, TRANQUIL TRI-COE, TRANQUIL TRI-CIC is ESD.

Related Clinical Trials

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.

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Other records listing General Hearing Instruments, 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.

K061459TRANQUIL TRI-BTEK971399AURIS AE, AURIS TL, AURIS HS, AURIS AC, AURIS MM, AURIS COE, AURIS CICK943144AURIS CICK850123IN-TH-EAR HEARING AID

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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