510(k) K071911

CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR by Innovision A/S — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2007
Date Received
July 11, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type