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FDA 510(k) Application Details - K191331
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
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510(K) Number
K191331
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
BraveHeart Wireless, Inc.
11 Perimeter Road
Nashua, NH 03063 US
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Contact
Balaji Sudabattula
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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
05/16/2019
Decision Date
06/12/2019
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
Y
Expedited Review
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