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510(k) K142425

Uroflowmeter by Be Technologies, Inc. — Product Code EXY

K142425 is an FDA 510(k) premarket notification submitted by Be Technologies, Inc. for the device "Uroflowmeter". The FDA issued a decision of Substantially Equivalent on October 27, 2014. 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
October 27, 2014
Date Received
August 29, 2014
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

  • K022721 — UROPOWER (August 26, 2003)
  • K971913 — GR100F URINE FLOWMETER (September 19, 1997)
  • 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