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FDA 510(k)

HI-69E, HI-69N, HI-69P

K-Number: K974129 · 1997-12-12

ApplicantRockwin Corp.
Decision Date1997-12-12
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

HI-69E, HI-69N, HI-69P is the device name listed in this FDA 510(k) record. The listed applicant is Rockwin Corp.. It received FDA 510(k) clearance on 1997-12-12 under 510(k) number K974129. 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 HI-69E, HI-69N, HI-69P?

HI-69E, HI-69N, HI-69P is a medical device that received FDA 510(k) clearance on 1997-12-12. The listed applicant is Rockwin Corp.. The 510(k) number is K974129.

When did HI-69E, HI-69N, HI-69P receive FDA 510(k) clearance?

HI-69E, HI-69N, HI-69P received FDA 510(k) clearance on 1997-12-12, under 510(k) number K974129.

Who is the listed applicant for HI-69E, HI-69N, HI-69P?

The FDA 510(k) record lists Rockwin Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HI-69E, HI-69N, HI-69P?

The FDA product code for HI-69E, HI-69N, HI-69P is ESD.

Other records listing Rockwin Corp. 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.

K943808RIONET HM-02K935559HEARING AIDS HB-36M, HB-36MS, HB-36MT, HI-67P, EXCEL-1000

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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