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Battery Pack for MCV100 and MCV200 Emergency Ventilators

by Allied Healthcare Products, Inc. 510(k)

Active United States

510(k) K083507

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK083507 Date18 May 2009ClearedStatusActive

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  • Withdrawn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
BTL
Device Class
Class II
Regulation
21 CFR Part 868.5925
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent

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