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510(k) K911091

DIAGNOSTIC ULTRASOUND/URO-GYN UDS 2000 SERIES by Diagnostic Ultrasound Corp. — Product Code FAP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1991
Date Received
March 12, 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

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  • K911125 — DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 (August 15, 1991)

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  • K931175 — SCHUSTER DISPOSABLE BALLOON PROBE (April 1, 1994)
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  • K922476 — URO-PRO 2000 (July 20, 1993)
  • K924383 — SYNECTICS LIBERTY SYSTEM, PC POLYGRAF/POLYGRAM URO (June 18, 1993)
  • K923995 — URODYNAMICS TUBING KITS #5161, #5150, #7170 (April 8, 1993)
  • K923464 — URODYNAMIC CATHETERS (February 5, 1993)