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FDA 510(k)

PREMIER PLUS

K-Number: K032003 · 2004-01-07

ApplicantAmerican Imex
Decision Date2004-01-07
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PREMIER PLUS is the device name listed in this FDA 510(k) record. The listed applicant is American Imex. It received FDA 510(k) clearance on 2004-01-07 under 510(k) number K032003. 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 PLUS?

PREMIER PLUS is a medical device that received FDA 510(k) clearance on 2004-01-07. The listed applicant is American Imex. The 510(k) number is K032003.

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

PREMIER PLUS received FDA 510(k) clearance on 2004-01-07, under 510(k) number K032003.

Who is the listed applicant for PREMIER PLUS?

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 PLUS?

The FDA product code for PREMIER PLUS 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.

K982221PREMIER APK926326MICROCARE(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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