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510(k) K143035

Flight 60 Ventilator by Flight Medical Innovations , Ltd. — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2016
Date Received
October 22, 2014
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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  • K120726 — FLIGHT 60 VENTILATOR (July 6, 2012)
  • K111683 — FLIGHT 60 VENTILATOR (October 31, 2011)

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