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510(k) K920664

DIAGNOSTIC ULTRASOUND/URO-GYN UPS 2020, GI VERSION by Diagnostic Ultrasound Corp. — Product Code FFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 1993
Date Received
February 13, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Gastrointestinal Motility (Electrical)
Device Class
Class II
Regulation Number
876.1725
Review Panel
GU
Submission Type

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  • K982568 — BLADDERMANAGER PCI 5000 MODEL 1002 (January 25, 1999)
  • K963585 — BLADDER MANAGER PCI 5000, BLADDERSCAN BVI 5000 (October 1, 1996)
  • K955840 — BLADDERMANAGER PCI 5000 / BLADDERSCAN BVI 5000 (May 24, 1996)
  • K955942 — BLADDERSCAN BVI 5000 (March 15, 1996)
  • 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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