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FDA 510(k)

HEARTLAND TECHNOLOGIES, ITE, ITC, CIC

K-Number: K971845 · 1997-08-15

ApplicantSound Hearing Instruments, Inc.
Decision Date1997-08-15
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HEARTLAND TECHNOLOGIES, ITE, ITC, CIC is the device name listed in this FDA 510(k) record. The listed applicant is Sound Hearing Instruments, Inc.. It received FDA 510(k) clearance on 1997-08-15 under 510(k) number K971845. 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 HEARTLAND TECHNOLOGIES, ITE, ITC, CIC?

HEARTLAND TECHNOLOGIES, ITE, ITC, CIC is a medical device that received FDA 510(k) clearance on 1997-08-15. The listed applicant is Sound Hearing Instruments, Inc.. The 510(k) number is K971845.

When did HEARTLAND TECHNOLOGIES, ITE, ITC, CIC receive FDA 510(k) clearance?

HEARTLAND TECHNOLOGIES, ITE, ITC, CIC received FDA 510(k) clearance on 1997-08-15, under 510(k) number K971845.

Who is the listed applicant for HEARTLAND TECHNOLOGIES, ITE, ITC, CIC?

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

What is the FDA product code for HEARTLAND TECHNOLOGIES, ITE, ITC, CIC?

The FDA product code for HEARTLAND TECHNOLOGIES, ITE, ITC, 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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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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