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510(k) K910444

BROWNE MEDICAL SYSTEMS IMAGEPRO by Browne Medical Systems, Inc. — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1991
Date Received
January 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Device Class
Class II
Regulation Number
876.1620
Review Panel
GU
Submission Type

Other clearances by Browne Medical Systems, Inc.

  • K920992 — PROFILE PLUS URODYNAMICS MEASURING SYST, MODIFIED (April 10, 1992)
  • K921047 — MODEL 8100 URODYNAMICS MEASURING SYSTEM (April 10, 1992)
  • K920991 — IMAGE PRO URODYNAMICS MEASURING SYST, MODIFICATION (April 10, 1992)
  • K910371 — URODYNAMIC MEASURING SYSTEM (May 15, 1991)
  • K910285 — BROWNE MEDICAL SYST.INC STAND-ALONE WATER PUMP (April 2, 1991)
  • K910217 — MINIPRO 8100 URODYNAMIC MEASUREING SYSTEM (April 2, 1991)

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  • K931175 — SCHUSTER DISPOSABLE BALLOON PROBE (April 1, 1994)
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  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K923464 — URODYNAMIC CATHETERS (February 5, 1993)