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510(k) K993765

QUANTITATIVE ANALYSIS OF LEFT VENTRICULAR ANGIOGRAMS (QLV) by Medis Medical Imaging Systems BV — Product Code IZI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 1999
Date Received
November 8, 1999
Clearance Type
Special
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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