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MT9000 Chart Recorder

by Astro-Med, Inc. 510(k)

Active United States

510(k) K892067

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK892067 Date5 Jun 1989ClearedStatusActive

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  • Withdrawn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 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DSH
Device Class
Class II
Regulation
21 CFR Part 870.2800
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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