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510(k) K073179

SERVO-I VENTILATOR SYSTEM MODEL 64 87 800 E4073, HELIOX OPTION, MODEL 6675585 by Maquet Critical Care AB — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 9, 2008
Date Received
November 13, 2007
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

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