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510(k) K241556

Cardiac Workstation (5000); Cardiac Workstation (7000) by Philips Medizin Systeme Böblingen GmbH — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2024
Date Received
May 31, 2024
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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