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

Gown, Examination

21 CFR 880.6265 / General Hospital
FDA source (opens on fda.gov)

FME is the FDA product code for Gown, Examination, a class I device type, regulated under 21 CFR 880.6265. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
FME
Device name
Gown, Examination
Regulation
21 CFR 880.6265
Device class
Class I
Review panel
General Hospital
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
5
Ingested recalls
1

Clearances, product code FME

By decision year
5 clearances under product code FME with a decision year between 1976 and 1988, 1976 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FME by decision year
YearClearances
19762
19771
19811
19881

Applicants with the most clearances

Product code FME
Applicants holding the most 510(k) clearances under product code FME
ApplicantClearances
American Hospital Supply1
General Medical Co.1
Graham Manufacturing Co.1
Kimberly-Clark Corporation1
Precept, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 237 companies shown, in name order