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510(k) K051222

AV-S ANAESTHESIA VENTILATOR by Penlon Limited — Product Code CBK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2005
Date Received
May 12, 2005
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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