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

Monitor, Temperature, Dialysis

21 CFR 876.5820 / Gastroenterology, Urology
FDA source (opens on fda.gov)

FLA is the FDA product code for Monitor, Temperature, Dialysis, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FLA
Device name
Monitor, Temperature, Dialysis
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
0

Clearances, product code FLA

By decision year
3 clearances under product code FLA with a decision year between 1981 and 2014, 1981 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FLA by decision year
YearClearances
19811
19841
20141

Applicants with the most clearances

Product code FLA
Applicants holding the most 510(k) clearances under product code FLA
ApplicantClearances
Laminar Flow Industries1
NxStage Medical Inc1
bioMerieux, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code