FDA 510(k) Application Details - K241556

Device Classification Name Electrocardiograph

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510(K) Number K241556
Device Name Electrocardiograph
Applicant Philips Medizin Systeme B÷blingen GmbH
Hewlett-Packard Strasse 2
B÷blingen 71032 DE
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Contact Angel Ya
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Regulation Number 870.2340

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Classification Product Code DPS
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Date Received 05/31/2024
Decision Date 12/17/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241556


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