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510(k) K221141

PageWriter TC35 Cardiograph by Medizin Systeme Boblingen GmbH — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2022
Date Received
April 19, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

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