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FDA 510(k)

LONG LIFE RX-12

K-Number: K960295 · 1996-03-22

ApplicantRexton, Inc.
Decision Date1996-03-22
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

LONG LIFE RX-12 is the device name listed in this FDA 510(k) record. The listed applicant is Rexton, Inc.. It received FDA 510(k) clearance on 1996-03-22 under 510(k) number K960295. 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 LONG LIFE RX-12?

LONG LIFE RX-12 is a medical device that received FDA 510(k) clearance on 1996-03-22. The listed applicant is Rexton, Inc.. The 510(k) number is K960295.

When did LONG LIFE RX-12 receive FDA 510(k) clearance?

LONG LIFE RX-12 received FDA 510(k) clearance on 1996-03-22, under 510(k) number K960295.

Who is the listed applicant for LONG LIFE RX-12?

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 LONG LIFE RX-12?

The FDA product code for LONG LIFE RX-12 is ESD.

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 ATCK954922REXTON'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/PCK944851MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC

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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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