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

Urinometer, Mechanical

21 CFR 876.1800 / Gastroenterology, Urology
FDA source (opens on fda.gov)

EXR is the FDA product code for Urinometer, Mechanical, a class II device type, regulated under 21 CFR 876.1800. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
EXR
Device name
Urinometer, Mechanical
Regulation
21 CFR 876.1800
Device class
Class II
Review panel
Gastroenterology, Urology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
9
Ingested recalls
0

Clearances, product code EXR

By decision year
9 clearances under product code EXR with a decision year between 1977 and 1994, 1977 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code EXR by decision year
YearClearances
19774
19871
19901
19911
19931
19941

Applicants with the most clearances

Product code EXR
Applicants holding the most 510(k) clearances under product code EXR
ApplicantClearances
Brother Scientific Products, Inc.2
C.R. Bard Inc1
Fraass Survival Systems, Inc.1
Kendall Healthcare Products Co. Div.Of Tyco Health1
Key Medical Services, Inc.1
Puritas Health Care, Inc.1
Unoplast A/S1
Will Ross Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order