Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph

Electrocardiograph

Philips Medical Systems

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Page Writer Tc20 Cardiograph, Page Writer Tc30 Cardiograph, Page Writer Tc50 Cardiograph, Page Writer Tc70 Cardiograph.

Pre-market Notification Details

Device IDK210560
510k NumberK210560
Device Name:Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
ClassificationElectrocardiograph
Applicant Philips Medical Systems Building A2, #718 Lingshi Road, Jingan District Shanghai,  CN 200072
ContactHong Zhu
CorrespondentHong Zhu
Philips Medical Systems Building A2, #718 Lingshi Road, Jingan District Shanghai,  CN 200072
Product CodeDPS  
CFR Regulation Number870.2340 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-02-25
Decision Date2021-06-30

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