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FDA 510(k) Application Details - K183282
Device Classification Name
More FDA Info for this Device
510(K) Number
K183282
Device Name
Biovitals Analytics Engine
Applicant
Biofourmis Singapore Pte. Ltd
Vision Exchange, #07-15, 2 Venture Drive
Singapore 608526 SG
Other 510(k) Applications for this Company
Contact
Kuldeep Singh Rajput
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PLB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/26/2018
Decision Date
08/15/2019
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
N
Expedited Review
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