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510(k) K223120

Ventoux VC2; Ventoux VC3 by Flight Medical Innovations , Ltd. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2024
Date Received
October 3, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Continuous, Facility Use
Device Class
Class II
Regulation Number
868.5895
Review Panel
AN
Submission Type

Other clearances by Flight Medical Innovations , Ltd.

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  • K130171 — FLIGHT 60 VENTILATOR (April 8, 2014)
  • K120726 — FLIGHT 60 VENTILATOR (July 6, 2012)
  • K111683 — FLIGHT 60 VENTILATOR (October 31, 2011)

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