KENDALL PEDIATRIC URINE METER— 510(k) K911258

Name: FDA 510(k) clearance K911258
Creator: U.S. Food and Drug Administration
Published: 1991-04-25

Substantially Equivalent

Kendall Healthcare Products Co. Div.Of Tyco Health

FDA 510(k) clearance K911258 for KENDALL PEDIATRIC URINE METER, Substantially Equivalent on 1991-04-25. Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health. Device class: 2.

Clearance details

Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
Product code: Code EXR
Device class: Class 2
Regulation: 21 CFR 876.1800
Advisory panel: Gastroenterology, Urology
Date received: 1991-03-22
Decision date: 1991-04-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mansfield, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EXR

view all

K934142 — URINARY DRAINAGE BAG1994-05-17
K935578 — URINE METER1993-12-17
K896732 — UNOMETER 5001990-11-02
K870240 — COMPRESS AND SKULLCAP, HEAD DRESSING1987-02-20
K771561 — DOVER URINE METER1977-09-07

More clearances from Kendall Healthcare Products Co. Div.Of Tyco Health

view all

K973763 — KENDALL CURITY IODOFORM PACKING STRIP1997-12-31
K973511 — KENDALL CURITY PETROLATUM GAUZE1997-12-16
K973507 — KENDALL XEROFORM PETROLATUM DRESSING (6311,6312,6313,6314,6315,6316,6317)1997-12-15
K973619 — KENDALL CURITY NON-ADHERING DRESSING1997-12-10
K973509 — KENDALL CURASORB ZN + MG ALGINATE WOUND DRESSING1997-12-04

Data sourced from openFDA. This site is unofficial and independent of the FDA.