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510(k) K200337

FloPatch (FP120) by Flosonics Medical (R/A 1929803 Ontario Corp.) — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2020
Date Received
February 11, 2020
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.)

  • K191388 — FloPatch (FP110) (June 21, 2019)

Other clearances for product code DPW

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  • K211589 — VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charge (January 27, 2022)
  • K212065 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (October 7, 2021)
  • K201114 — Bidop 7 (January 5, 2021)