PulseFlowDF— 510(k) K150806

Substantially Equivalent

Pulseflow Technologies

FDA 510(k) clearance K150806 for PulseFlowDF, Substantially Equivalent on 2015-12-16. Applicant: Pulseflow Technologies. Device class: 2.

Clearance details

Applicant: Pulseflow Technologies
Product code: Code JOW
Device class: Class 2
Regulation: 21 CFR 870.5800
Advisory panel: Cardiovascular
Date received: 2015-03-26
Decision date: 2015-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Aylesbury, GB

Download summary PDF View on FDA.gov ↗

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