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510(k) K072926

HELONTIX VENT by Linde Gas Therapeutics — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2008
Date Received
October 15, 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

Other clearances by Linde Gas Therapeutics

  • K063354 — LINDE INTEGRATED VALVE (LIV) (April 17, 2007)

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