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FDA 510(k) Application Details - K191738
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K191738
Device Name
Electrocardiograph
Applicant
Philips Medical Systems
Building A2, #718 Lingshi Road, JingAn District
Shanghai 200072 CN
Other 510(k) Applications for this Company
Contact
Hong Zhu
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/28/2019
Decision Date
09/29/2020
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
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