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510(k) K911584

DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 by Pie Medical Equipment B.V. — Product Code IYO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1991
Date Received
April 8, 1991
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 Pie Medical Equipment B.V.

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  • K945540 — CAAS II (June 28, 1995)
  • K915647 — DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250 (November 9, 1992)
  • K912819 — SC1150 CW/PD (January 9, 1992)
  • K911043 — HEMISPHERE MULTIPLANE ENDORECTAL PROBE (October 9, 1991)
  • K911044 — 7.5 MHZ APAS TRANSDUCER (ART.NOL: 50.04918.1) (October 7, 1991)
  • K900838 — TRANSVAGINAL TRANSDUCER ASSEMBLY (May 23, 1990)

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