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510(k) K183282

Biovitals Analytics Engine by Biofourmis Singapore Pte., Ltd. — Product Code PLB

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 15, 2019
Date Received: November 26, 2018
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Multivariate Vital Signs Index
Device Class: Class II
Regulation Number: 870.2300
Review Panel: CV
Submission Type

Automated calculation of a summary index (or indices) based on several individual measured vital sign inputs.