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510(k) K982203

CAAS II LVA BIPLANE OPTION by Pie Medical Equipment B.V. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 14, 1998
Date Received
June 22, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Angiographic
Device Class
Class II
Regulation Number
892.1600
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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