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by Demite Limited 510(k)

Active United States

510(k) K001003

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK001003 Date10 Dec 2001ClearedStatusActive

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  • Withdrawn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
FMW
Device Class
Class I
Regulation
21 CFR Part 880.6190
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent