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510(k) K954581

ARC SERIES by Continental X-Ray Corp. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1995
Date Received
October 2, 1995
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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  • K950571 — LINEAR FR TOMOGRAPHIC SYSTEM: 0MT 8000, MODEL NO. 6681.270 (March 31, 1995)
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  • K942100 — MODEL TM EP HIGH VOLTAGE GENERATOR (June 7, 1994)
  • K934686 — MOLYBDENUM/RHODIUM FILTERS (May 26, 1994)
  • K931724 — ELECTROPHYSIOLOGY (EP) TABLE EP 2000 SERIES (June 14, 1993)
  • K925934 — WALL BUCKY HOLDERS LT. & RT. HAND, & CENTER MOUNT (March 4, 1993)
  • K921986 — PATIENT INFORMATION MANAGER (PIM) (October 16, 1992)

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