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510(k) K915342

UD 2000 VIDEO OPTION by Diagnostic Ultrasound Corp. — Product Code LLZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 1992
Date Received
November 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Image Processing, Radiological
Device Class
Class II
Regulation Number
892.2050
Review Panel
RA
Submission Type

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  • 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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