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510(k) K971913

GR100F URINE FLOWMETER by Albyn Medical , Ltd. — Product Code EXY

K971913 is an FDA 510(k) premarket notification submitted by Albyn Medical , Ltd. for the device "GR100F URINE FLOWMETER". The FDA issued a decision of Substantially Equivalent on September 19, 1997. The device falls under product code EXY (Uroflowmeter), a Class II device regulated under 21 CFR 876.1800.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 1997
Date Received
May 22, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Uroflowmeter
Device Class
Class II
Regulation Number
876.1800
Review Panel
GU
Submission Type

Other clearances for product code EXY

  • K142425 — Uroflowmeter (October 27, 2014)
  • K022721 — UROPOWER (August 26, 2003)
  • K953999 — DANTEC DA CAPO (November 21, 1995)
  • K951442 — FLOLAB (August 24, 1995)
  • K944972 — URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRY (March 8, 1995)
  • K945495 — 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION (February 9, 1995)
  • K941105 — UORCAP,MODEL NUMBER UDS-UCAP (May 10, 1994)
  • K904557 — MICROFLO (December 28, 1990)
  • K902408 — DIAGNOSTIC ULTRASOUND UFS 1005 (August 10, 1990)
  • K900770 — HOME URODATA SYSTEM(TM) (June 8, 1990)

FDA data resources