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Am-50 Aerosol/Medication Air Compressor

by Preferred Medical Supply, Inc. 510(k)

Active United States

510(k) K945478

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945478 Date28 Sep 1995ClearedStatusActive

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  • Withdrawn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
BTI
Device Class
Class II
Regulation
21 CFR Part 868.6250
Advisory Committee
Anesthesiology
FDA Decision
SESE Substantially Equivalent