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FDA 510(k) Application Details - K210140
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K210140
Device Name
Electrocardiograph
Applicant
Edan Instruments, Inc
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District
Pingshan District
Shenzhen 518122 CN
Other 510(k) Applications for this Company
Contact
Ying Dai
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
01/19/2021
Decision Date
10/01/2021
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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