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510(k) K915647

DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC250 by Pie Medical Equipment B.V. — Product Code ITX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1992
Date Received
December 18, 1991
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

Other clearances by Pie Medical Equipment B.V.

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  • K911584 — DIAGNOSTIC ULTRASOUND SYSTEM MODEL SC480 (October 24, 1991)
  • 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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