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510(k) K941105

UORCAP,MODEL NUMBER UDS-UCAP by Laborie Medical Tech, Inc. — Product Code EXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 10, 1994
Date Received
March 7, 1994
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

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  • K991479 — VISER PENILE TUMESCENCE MONITOR (July 7, 1999)
  • K963064 — ANO-RECTAL MANOMETRY OPTION, MODEL NUMBER UDS-ARM (June 5, 1997)
  • K950016 — CART, MODE NUMBER UDS-CART (March 30, 1995)

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  • K945495 — 4-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTION (February 9, 1995)
  • K904557 — MICROFLO (December 28, 1990)
  • K902408 — DIAGNOSTIC ULTRASOUND UFS 1005 (August 10, 1990)
  • K900770 — HOME URODATA SYSTEM(TM) (June 8, 1990)