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FDA 510(k) Application Details - K200690
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
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510(K) Number
K200690
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
LifeSignals, Inc.
39355 California Street, Suite 305
Fremont, CA 94538 US
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Contact
Saravanan Balasubramanian
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Regulation Number
870.2910
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Classification Product Code
DRG
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More FDA Info for this Product Code
Date Received
03/16/2020
Decision Date
07/15/2020
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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