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510(k) K191388

FloPatch (FP110) by Flosonics Medical (R/A 1929803 Ontario Corp.) — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 21, 2019
Date Received
May 24, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Flowmeter, Blood, Cardiovascular
Device Class
Class II
Regulation Number
870.2100
Review Panel
CV
Submission Type

Other clearances by Flosonics Medical (R/A 1929803 Ontario Corp.)

  • K200337 — FloPatch (FP120) (March 24, 2020)

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  • K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (October 7, 2021)
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