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510(k) K002742

SPHYGMOCOR MX MODEL SCOR-MX by Pwv Medical Pty, Lt. — Product Code DSK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 2001
Date Received
September 1, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Blood-Pressure
Device Class
Class II
Regulation Number
870.1110
Review Panel
CV
Submission Type

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