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510(k) K130171

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2014
Date Received
January 24, 2013
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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  • K111683 — FLIGHT 60 VENTILATOR (October 31, 2011)

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