FDA 510(k)

MENS 2000-D

K-Number: K914441 · 1991-12-17

Decision Date1991-12-17

Product CodeGZJ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MENS 2000-D is the device name listed in this FDA 510(k) record. The listed applicant is Monad Corp.. It received FDA 510(k) clearance on 1991-12-17 under 510(k) number K914441. 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 2000-D?

MENS 2000-D is a medical device that received FDA 510(k) clearance on 1991-12-17. The listed applicant is Monad Corp.. The 510(k) number is K914441.

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

MENS 2000-D received FDA 510(k) clearance on 1991-12-17, under 510(k) number K914441.

Who is the listed applicant for MENS 2000-D?

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 2000-D?

The FDA product code for MENS 2000-D is GZJ.

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.

K902226MY-O-MATIC 5000I K904234MENS-O-MATIC I K904258MICRO DERM K904235MENS-O-MATIC 2000 K904260MENS-O-MATIC 3000 K904430MENS FREEDOM MICRO

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Related Devices (Code: GZJ)

K252712STIMPOD NMS460 Nerve StimulatorAlgiamed Technologies USA, Inc.K252767actiTENS miniSublimed K252236CP Relief Wand Rx - TENS/NMESN & C Holdings, LLC K232441Unipro (K-UNIPRO-US)Tenscare, Ltd.K241228TENSWaveZynex Medical Officer K233046Electrical 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.