FloPatch (FP110)— 510(k) K191388

Name: FDA 510(k) clearance K191388
Creator: U.S. Food and Drug Administration
Published: 2019-06-21

Substantially Equivalent

Flosonics Medical (R/A 1929803 Ontario Corp.)

FDA 510(k) clearance K191388 for FloPatch (FP110), Substantially Equivalent on 2019-06-21. Applicant: Flosonics Medical (R/A 1929803 Ontario Corp.). Device class: 2.

Clearance details

Applicant: Flosonics Medical (R/A 1929803 Ontario Corp.)
Product code: Code DPW
Device class: Class 2
Regulation: 21 CFR 870.2100
Advisory panel: Cardiovascular
Date received: 2019-05-24
Decision date: 2019-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sudbury, CA

Download summary PDF View on FDA.gov ↗

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