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510(k) K933664

POLYTRON T.O.P. (TIME, OPERATION, PERFORMANCE) by Siemens Gammasonics, Inc. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 15, 1993
Date Received
July 28, 1993
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

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  • K920309 — SIENET DIAGNOSTIC REPORTING CONSOLE (March 20, 1992)
  • K914313 — HICOR (November 27, 1991)
  • K914350 — ICON COMPUTER SYSTEM (November 22, 1991)

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