510(k) K103563

PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150 by Precision Medical, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 1, 2011
Date Received
December 6, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type