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510(k) K896732

UNOMETER 500 by Unoplast A/S — Product Code EXR

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)
  • K896730 — SUCTION CATHETER STRAIGHT/COUDE (March 30, 1990)
  • K896731 — OXYGEN CATHETERS (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)
  • K770423 — URINE TESTER, MODEL NO. 707 (June 3, 1977)
  • K770939 — URINE TESTER, MODEL 701 (June 3, 1977)
  • K761083 — BARD URINE METER W/ BAG (January 26, 1977)