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

Apparatus, Air Handling, Enclosure

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

FZI is the FDA product code for Apparatus, Air Handling, Enclosure, a class II device type, regulated under 21 CFR 878.5070. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FZI
Device name
Apparatus, Air Handling, Enclosure
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
5
Ingested recalls
0

Clearances, product code FZI

By decision year
5 clearances under product code FZI with a decision year between 1978 and 1991, 1978 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FZI by decision year
YearClearances
19782
19851
19912

Applicants with the most clearances

Product code FZI
Applicants holding the most 510(k) clearances under product code FZI
ApplicantClearances
Edward Weck, Inc.2
Alcon Laboratories1
Central Georgia Ancillary Health Systems1
E.M. Adams Co., Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code