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510(k) K935578

URINE METER by Puritas Health Care, Inc. — Product Code EXR

K935578 is an FDA 510(k) premarket notification submitted by Puritas Health Care, Inc. for the device "URINE METER". The FDA issued a decision of Substantially Equivalent on December 17, 1993. The device falls under product code EXR (Urinometer, Mechanical), a Class II device regulated under 21 CFR 876.1800. Puritas Health Care, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1993
Date Received
November 18, 1993
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 Puritas Health Care, Inc.

  • K942339 — SKIN NEUVEAU SCAR TREATMENT (November 28, 1994)
  • K941197 — SILK*SKIN SCAR TREATMENT (August 11, 1994)
  • K935600 — TRACHEAL SUCTION CATHETER (May 10, 1994)
  • K935531 — OP-FLEX SUMP SUCTION SET WITH DIFFUSER TIP (May 5, 1994)
  • K940074 — Y-TYPE BLOOD ADMINISTRATION SET (April 21, 1994)
  • K940054 — MEASURED VOLUME SOLUTION ADMINISTRATION SET (April 15, 1994)
  • K940055 — MULTISET (April 15, 1994)
  • K935583 — SUCTION SET, TRACHAEL (April 11, 1994)
  • K940056 — WINGED INFUSION SET A-PORT VASCULAR ACCESS SYSTEM (April 4, 1994)
  • K935532 — TRANSFER SET (April 4, 1994)

Other clearances for product code EXR

  • K934142 — URINARY DRAINAGE BAG (May 17, 1994)
  • K911258 — KENDALL PEDIATRIC URINE METER (April 25, 1991)
  • K896732 — UNOMETER 500 (November 2, 1990)
  • 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)

FDA data resources