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FDA 510(k)

PREMIER AP

K-Number: K982221 · 1998-09-22

ApplicantAmerican Imex
Decision Date1998-09-22
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PREMIER AP is the device name listed in this FDA 510(k) record. The listed applicant is American Imex. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K982221. 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 PREMIER AP?

PREMIER AP is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is American Imex. The 510(k) number is K982221.

When did PREMIER AP receive FDA 510(k) clearance?

PREMIER AP received FDA 510(k) clearance on 1998-09-22, under 510(k) number K982221.

Who is the listed applicant for PREMIER AP?

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

What is the FDA product code for PREMIER AP?

The FDA product code for PREMIER AP is GZJ.

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Other records listing American Imex 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.

K032003PREMIER PLUSK926326MICROCARE(TM)K912289ULTIMA XS, MODIFICATIONK895295ULTIMA XS MICROCURRENT TENSK894388ZIMMER TENSK881704EASY TENS

View all 11 devices →

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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