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FDA 510(k)

MENS-O-MATIC 2000

K-Number: K904235 · 1991-05-13

ApplicantMonad Corp.
Decision Date1991-05-13
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MENS-O-MATIC 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Monad Corp.. It received FDA 510(k) clearance on 1991-05-13 under 510(k) number K904235. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MENS-O-MATIC 2000?

MENS-O-MATIC 2000 is a medical device that received FDA 510(k) clearance on 1991-05-13. The listed applicant is Monad Corp.. The 510(k) number is K904235.

When did MENS-O-MATIC 2000 receive FDA 510(k) clearance?

MENS-O-MATIC 2000 received FDA 510(k) clearance on 1991-05-13, under 510(k) number K904235.

Who is the listed applicant for MENS-O-MATIC 2000?

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

What is the FDA product code for MENS-O-MATIC 2000?

The FDA product code for MENS-O-MATIC 2000 is GZJ.

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Other records listing Monad 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.

K914441MENS 2000-DK902226MY-O-MATIC 5000IK904258MICRO DERMK904260MENS-O-MATIC 3000K904430MENS FREEDOM MICROK904288MENS-O-MATIC 1XS AND MENS-O-MATIC 2XS

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Related Devices (Code: GZJ)

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.

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimedK252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLCK232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical OfficerK233046Electrical Neuromuscular Stimulator, Cure TrioOriental Inspiration Limited

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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