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Premier Ap

by American Imex

510(k) K982221

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK982221 Date22 Sep 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
GZJ
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Premier Ap is a Class 2 Neurology device with product code GZJ, manufactured by American Imex. It is a medical device designed for neurology applications.

The device is supplied by American Imex and has FDA 510(k) clearance with number K982221, granted on September 22, 1998. It was cleared through the Traditional 510(k) pathway after a 90-day FDA review.

Other devices from American Imex

See all devices from American Imex →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the PREMIER AP device used for?

    The PREMIER AP is a Class 2 Neurology device designed for neurology applications. It has product code GZJ and is manufactured by American Imex.

  • What is the regulatory status of the PREMIER AP?

    The PREMIER AP has FDA 510(k) clearance with number K982221, granted on September 22, 1998. It was cleared through the Traditional 510(k) pathway after a 90-day FDA review.

  • Who manufactures the PREMIER AP and where is it supplied from?

    The PREMIER AP is manufactured by American Imex, located at 16520 Aston St., Irvine, CA 92606, US. The device is supplied directly from this manufacturer.

  • What advisory committee reviewed the PREMIER AP?

    The PREMIER AP was reviewed by the Neurology advisory committee (NE) as part of its FDA 510(k) clearance process. This committee specializes in neurology-related medical devices.