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Data Master Perfusion Monitoring System

by Dideco 510(k)

Active United States

510(k) K001388

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK001388 Date28 Jul 2000ClearedStatusActive

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  • Withdrawn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
DRY
Device Class
Class II
Regulation
21 CFR Part 870.4330
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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