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510(k) K963585

BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 by Diagnostic Ultrasound Corp. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 1, 1996
Date Received
September 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Imaging, Pulsed Echo, Ultrasonic
Device Class
Class II
Regulation Number
892.1560
Review Panel
RA
Submission Type

Other clearances by Diagnostic Ultrasound Corp.

  • K030763 — DIAGNOSTIC ULTRASOUND BLADDERMASS BVM 6500 ULTRASOUND SYSTEM (March 26, 2003)
  • K022153 — BLADDERSCAN BVI 6100 (August 15, 2002)
  • K982568 — BLADDERMANAGER PCI 5000 MODEL 1002 (January 25, 1999)
  • K955840 — BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 (May 24, 1996)
  • K955942 — BLADDERSCAN BVI 5000 (March 15, 1996)
  • K920664 — DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION (December 23, 1993)
  • K915342 — UD 2000 VIDEO OPTION (June 10, 1992)
  • K915436 — BLADDERSCAN BVI 2500 (March 3, 1992)
  • K911166 — DIAGNOSTIC ULTRASOUND/URO-GYN UD 511 (August 15, 1991)
  • K911125 — DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020 (August 15, 1991)

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