510(k) K023805

LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 by Laerdal Medical A/S — Product Code CBP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 11, 2003
Date Received
November 14, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Valve, Non-Rebreathing
Device Class
Class II
Regulation Number
868.5870
Review Panel
AN
Submission Type