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510(k) K971176

VIEW ARCHIVING STATION by Electromed Intl., Ltd. — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1997
Date Received
March 31, 1997
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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