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510(k) K770939

URINE TESTER, MODEL 701 by Brother Scientific Products, Inc. — Product Code EXR

K770939 is an FDA 510(k) premarket notification submitted by Brother Scientific Products, Inc. for the device "URINE TESTER, MODEL 701". The FDA issued a decision of Substantially Equivalent on June 3, 1977. The device falls under product code EXR (Urinometer, Mechanical), a Class II device regulated under 21 CFR 876.1800. Brother Scientific Products, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1977
Date Received
May 23, 1977
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 Brother Scientific Products, Inc.

  • K770423 — URINE TESTER, MODEL NO. 707 (June 3, 1977)

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)
  • 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)
  • K761083 — BARD URINE METER W/ BAG (January 26, 1977)

FDA data resources