510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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FZHClass II

Apparatus, Air Handling, Room

21 CFR 878.5070 / General, Plastic Surgery
FDA source (opens on fda.gov)

FZH is the FDA product code for Apparatus, Air Handling, Room, a class II device type, regulated under 21 CFR 878.5070. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FZH
Device name
Apparatus, Air Handling, Room
Regulation
21 CFR 878.5070
Device class
Class II
Review panel
General, Plastic Surgery
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
4
Ingested recalls
0

Clearances, product code FZH

By decision year
4 clearances under product code FZH with a decision year between 1977 and 1993, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FZH by decision year
YearClearances
19771
19871
19881
19931

Applicants with the most clearances

Product code FZH
Applicants holding the most 510(k) clearances under product code FZH
ApplicantClearances
Cardio-Med-Associates, Inc.1
Custom Industries, Inc.1
Dupaco, Inc.1
Spec Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code