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FDA 510(k) Application Details - K220350
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K220350
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
AliveCor, Inc.
189 N. Bernardo Ave. Suite 100
Mountain View, CA 94043 US
Other 510(k) Applications for this Company
Contact
Susan Noriega
Other 510(k) Applications for this Contact
Regulation Number
870.2920
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Classification Product Code
DXH
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More FDA Info for this Product Code
Date Received
02/07/2022
Decision Date
05/25/2022
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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