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FDA 510(k)

M-29 PP-PC, M-29 PP-O/PC

K-Number: K950451 · 1995-03-21

ApplicantRexton, Inc.
Decision Date1995-03-21
Product CodeESD
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

M-29 PP-PC, M-29 PP-O/PC is the device name listed in this FDA 510(k) record. The listed applicant is Rexton, Inc.. It received FDA 510(k) clearance on 1995-03-21 under 510(k) number K950451. 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 M-29 PP-PC, M-29 PP-O/PC?

M-29 PP-PC, M-29 PP-O/PC is a medical device that received FDA 510(k) clearance on 1995-03-21. The listed applicant is Rexton, Inc.. The 510(k) number is K950451.

When did M-29 PP-PC, M-29 PP-O/PC receive FDA 510(k) clearance?

M-29 PP-PC, M-29 PP-O/PC received FDA 510(k) clearance on 1995-03-21, under 510(k) number K950451.

Who is the listed applicant for M-29 PP-PC, M-29 PP-O/PC?

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 M-29 PP-PC, M-29 PP-O/PC?

The FDA product code for M-29 PP-PC, M-29 PP-O/PC 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 ATCK960295LONG LIFE RX-12K954922REXTON'S HORIZION FAMILY OF MULTIPLE SITUATION, SINGLE CHANNEL PROGRAMMBALE INSTRUMENTSK953770REXTON MINI-PRIMO PLUS, PP142, D.C .H.I. FAMILYK944851MICRO MINI PRIMO AGC, MICRO-MINI PRIMO S-AGC

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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