DeviceClearance

FloPatch (FP120)— 510(k) K200337

Substantially Equivalent

Flosonics Medical (R/A 1929803 Ontario Corp.)

FDA 510(k) clearance K200337 for FloPatch (FP120), Substantially Equivalent on 2020-03-24. 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
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Toronto, CA
Download summary PDFView on FDA.gov ↗

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More clearances from Flosonics Medical (R/A 1929803 Ontario Corp.)

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Recalls naming K200337

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200337.

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