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510(k) K896732

UNOMETER 500 by Unoplast A/S — Product Code EXR

K896732 is an FDA 510(k) premarket notification submitted by Unoplast A/S for the device "UNOMETER 500". The FDA issued a decision of Substantially Equivalent on November 2, 1990. The device falls under product code EXR (Urinometer, Mechanical), a Class II device regulated under 21 CFR 876.1800. Unoplast A/S has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 2, 1990
Date Received
November 30, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urinometer, Mechanical
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
Submission Type

Other clearances by Unoplast A/S

  • K896734 — FEEDING TUBE (December 21, 1990)
  • K896729 — NELATON-, FEMALE - OR TIEMANN CATHETER (November 5, 1990)
  • K896731 — OXYGEN CATHETERS (March 30, 1990)
  • K896730 — SUCTION CATHETER STRAIGHT/COUDE (March 30, 1990)
  • K896733 — VACCON (February 1, 1990)
  • K802248 — DISARP ORIGINAL (September 26, 1980)

Other clearances for product code EXR

  • K934142 — URINARY DRAINAGE BAG (May 17, 1994)
  • K935578 — URINE METER (December 17, 1993)
  • K911258 — KENDALL PEDIATRIC URINE METER (April 25, 1991)
  • K870240 — COMPRESS AND SKULLCAP, HEAD DRESSING (February 20, 1987)
  • K771561 — DOVER URINE METER (September 7, 1977)
  • K770939 — URINE TESTER, MODEL 701 (June 3, 1977)
  • K770423 — URINE TESTER, MODEL NO. 707 (June 3, 1977)
  • K761083 — BARD URINE METER W/ BAG (January 26, 1977)

FDA data resources