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510(k) K051322

PNEUPAC VRI STANDARD, MODEL VRISTDNUS, PNEUPAC VRI RESPONDER, MODEL VRIRESNUS by Smiths Medical International , Ltd. — Product Code BTL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 5, 2005
Date Received
May 20, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ventilator, Emergency, Powered (Resuscitator)
Device Class
Class II
Regulation Number
868.5925
Review Panel
AN
Submission Type

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