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510(k) K926560

EPIC (ELECTROPHYSIOLOGY IMAGING COMPUTER by Fischer Imaging Corp. — Product Code JAA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1994
Date Received
December 31, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Device Class
Class II
Regulation Number
892.1650
Review Panel
RA
Submission Type

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  • K950291 — DIGITAL 625HF (March 23, 1995)
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