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Asc-954 Integrator Amplifier

by Astro-Med, Inc. 510(k)

Active United States

510(k) K896164

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK896164 Date22 Jan 1990ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
GWK
Device Class
Class II
Regulation
21 CFR Part 882.1845
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent

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