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510(k) K982568

BLADDERMANAGER PCI 5000 MODEL 1002 by Diagnostic Ultrasound Corp. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 1999
Date Received
July 23, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transducer, Ultrasonic, Diagnostic
Device Class
Class II
Regulation Number
892.1570
Review Panel
RA
Submission Type

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  • 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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