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510(k) K880504

MCT MEDICAL BROWNE UROSCAN URODYNAMIC by Mct Medical, Inc. — Product Code EXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 17, 1988
Date Received
February 5, 1988
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 by Mct Medical, Inc.

  • K874606 — CATHRA GRAM POSITIVE SCREEN (May 6, 1988)
  • K861958 — REPLIANALYZER (August 1, 1986)

Other clearances for product code EXY

  • K142425 — Uroflowmeter (October 27, 2014)
  • 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)