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FDA 510(k)

DEEP CANAL HEARING INSTRUMENT

K-Number: K942702 · 1994-12-21

ApplicantRexton, Inc.
Decision Date1994-12-21
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

DEEP CANAL HEARING INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Rexton, Inc.. It received FDA 510(k) clearance on 1994-12-21 under 510(k) number K942702. 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 DEEP CANAL HEARING INSTRUMENT?

DEEP CANAL HEARING INSTRUMENT is a medical device that received FDA 510(k) clearance on 1994-12-21. The listed applicant is Rexton, Inc.. The 510(k) number is K942702.

When did DEEP CANAL HEARING INSTRUMENT receive FDA 510(k) clearance?

DEEP CANAL HEARING INSTRUMENT received FDA 510(k) clearance on 1994-12-21, under 510(k) number K942702.

Who is the listed applicant for DEEP CANAL HEARING INSTRUMENT?

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

What is the FDA product code for DEEP CANAL HEARING INSTRUMENT?

The FDA product code for DEEP CANAL HEARING INSTRUMENT is ESD.

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Other records listing Rexton, 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.

K970537REXTON MODEL 48 AND 49PPK964451PICCOLO K-AMP VC+, PICCOLO P-A1, PICCOLO P-AO AND PICCOLO ATCK960295LONG LIFE RX-12K954922REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTSK953770REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILYK950451M-29 PP-PC, M-29 PP-O/PC

View all 21 devices →

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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