Cleared Traditional

Biovitals Analytics Engine

K183282 · Biofourmis Singapore Pte., Ltd. · Cardiovascular
Aug 2019
Decision
262d
Days
Class 2
Risk

About This 510(k) Submission

K183282 is an FDA 510(k) clearance for the Biovitals Analytics Engine, a Multivariate Vital Signs Index (Class II — Special Controls, product code PLB), submitted by Biofourmis Singapore Pte., Ltd. (Singapore, SG). The FDA issued a Cleared decision on August 15, 2019, 262 days after receiving the submission on November 26, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K183282 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 2018
Decision Date August 15, 2019
Days to Decision 262 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code PLB — Multivariate Vital Signs Index
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300
Definition Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs.