Biovitals Analytics Engine— 510(k) K183282

Name: FDA 510(k) clearance K183282
Creator: U.S. Food and Drug Administration
Published: 2019-08-15

Substantially Equivalent

Biofourmis Singapore Pte., Ltd.

FDA 510(k) clearance K183282 for Biovitals Analytics Engine, Substantially Equivalent on 2019-08-15. Applicant: Biofourmis Singapore Pte., Ltd.. Device class: 2.

Clearance details

Applicant: Biofourmis Singapore Pte., Ltd.
Product code: Code PLB
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2018-11-26
Decision date: 2019-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.