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FDA 510(k)

AMASTIM 2000

K-Number: K872704 · 1988-01-22

ApplicantAmatech International, Inc.
Decision Date1988-01-22
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

AMASTIM 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Amatech International, Inc.. It received FDA 510(k) clearance on 1988-01-22 under 510(k) number K872704. 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 AMASTIM 2000?

AMASTIM 2000 is a medical device that received FDA 510(k) clearance on 1988-01-22. The listed applicant is Amatech International, Inc.. The 510(k) number is K872704.

When did AMASTIM 2000 receive FDA 510(k) clearance?

AMASTIM 2000 received FDA 510(k) clearance on 1988-01-22, under 510(k) number K872704.

Who is the listed applicant for AMASTIM 2000?

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

What is the FDA product code for AMASTIM 2000?

The FDA product code for AMASTIM 2000 is GZJ.

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Other records listing Amatech International, 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.

K875049MD STRIPS BGK862806URINE DIAGNOSTIC REAGENT STRIPS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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