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510(k) K181912

Ascent Cardiorespiratory Diagnostic Software by Medical Graphics Corporation — Product Code BTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2019
Date Received
July 17, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Calculator, Predicted Values, Pulmonary Function
Device Class
Class II
Regulation Number
868.1890
Review Panel
AN
Submission Type

Other clearances by Medical Graphics Corporation

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