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

Device, Transfer, Patient, Manual

21 CFR 880.6785 / General Hospital
FDA source (opens on fda.gov)

FMR is the FDA product code for Device, Transfer, Patient, Manual, a class I device type, regulated under 21 CFR 880.6785. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FMR
Device name
Device, Transfer, Patient, Manual
Regulation
21 CFR 880.6785
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
0

Clearances, product code FMR

By decision year
5 clearances under product code FMR with a decision year between 1977 and 1987, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code FMR by decision year
YearClearances
19771
19791
19802
19871

Applicants with the most clearances

Product code FMR
Applicants holding the most 510(k) clearances under product code FMR
ApplicantClearances
Adel Medical, Ltd.1
Competent Design1
Gettner Enterprises, Inc.1
Patient Healthguards Corp.1
Skil-Care Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 240 companies shown, in name order