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

Meter, Conductivity, Induction, Remote Type

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

FLB is the FDA product code for Meter, Conductivity, Induction, Remote Type, a class II device type, regulated under 21 CFR 876.5820. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
FLB
Device name
Meter, Conductivity, Induction, Remote Type
Regulation
21 CFR 876.5820
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
6
Ingested recalls
0

Clearances, product code FLB

By decision year
6 clearances under product code FLB with a decision year between 1977 and 2010, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code FLB by decision year
YearClearances
19771
19821
19831
19881
19941
20101

Applicants with the most clearances

Product code FLB
Applicants holding the most 510(k) clearances under product code FLB
ApplicantClearances
Mesa Medical, Inc.2
Cobe Laboratories, Inc.1
Myron L Company1
Renal Systems, Inc.1
Western Laboratories Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code