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510(k) K241890

Device
Philips Holter Analysis System
Applicant
Philips Medizin Systeme Böblingen GmbH
510(k) number
K241890
Product code
MLO
Decision
Substantially Equivalent (SESE)
Decision date
2025-03-21
Date received
2024-06-28
Regulation
870.2800
Classification name
Electrocardiograph, Ambulatory, With Analysis Algorithm
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Cathy Hong
Address
Hewlett-Packard Strasse 2 Böblingen DE 71034 71034

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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