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FDA 510(k) Application Details - K201208
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K201208
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
LIVMOR
16470 Bake Pkwy., Ste. 200
Irvine, CA 92618 US
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Contact
Ken Persen
Other 510(k) Applications for this Contact
Regulation Number
870.2920
More FDA Info for this Regulation Number
Classification Product Code
DXH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/05/2020
Decision Date
09/23/2020
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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