FZH · Class II · 21 CFR 878.5070

FDA Product Code FZH: Apparatus, Air Handling, Room

Leading manufacturers include Dupaco, Inc., Custom Industries, Inc. and Spec Systems, Inc..

4
Total
4
Cleared
87d
Avg days
1977
Since

FDA 510(k) Cleared Apparatus, Air Handling, Room Devices (Product Code FZH)

4 devices
1–4 of 4
Cleared Mar 20, 1993
CARDIO-PAK LAPAROTOMY PACK
K923233
Cardio-Med-Associates, Inc.
General & Plastic Surgery · 262d
Cleared Jan 27, 1988
MODEL UCA / SPEC SYSTEM UCA
K875305
Spec Systems, Inc.
General & Plastic Surgery · 29d
Cleared Jun 01, 1987
ULTRAFLOW
K871901
Custom Industries, Inc.
General & Plastic Surgery · 17d
Cleared Feb 23, 1977
OPERATING ROOM VENTILATOR
K770084
Dupaco, Inc.
General & Plastic Surgery · 40d

About Product Code FZH - Regulatory Context