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FDA 510(k)

RCI EARMATE

K-Number: K823089 · 1983-01-21

ApplicantRci, Inc.
Decision Date1983-01-21
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

RCI EARMATE is the device name listed in this FDA 510(k) record. The listed applicant is Rci, Inc.. It received FDA 510(k) clearance on 1983-01-21 under 510(k) number K823089. 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 RCI EARMATE?

RCI EARMATE is a medical device that received FDA 510(k) clearance on 1983-01-21. The listed applicant is Rci, Inc.. The 510(k) number is K823089.

When did RCI EARMATE receive FDA 510(k) clearance?

RCI EARMATE received FDA 510(k) clearance on 1983-01-21, under 510(k) number K823089.

Who is the listed applicant for RCI EARMATE?

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

What is the FDA product code for RCI EARMATE?

The FDA product code for RCI EARMATE 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 Rci, 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.

K820878CONCHO PEDIATRIC PACK

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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