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510(k) K251114

FloPatch FP120 by Flosonics Medical — Product Code DPW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 20, 2025
Date Received
April 11, 2025
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

  • K223843 — FloPatch FP120 (May 3, 2023)
  • K222242 — FloPatch FP120 (December 9, 2022)

Other clearances for product code DPW

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  • K241583 — VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charge (August 30, 2024)
  • K223843 — FloPatch FP120 (May 3, 2023)
  • K222242 — FloPatch FP120 (December 9, 2022)
  • K213974 — GEM FLOW COUPLER Monitor (GEM1020M-2) (April 20, 2022)
  • 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)
  • K200337 — FloPatch (FP120) (March 24, 2020)