510(k) K113338

MEDICAL AIR COMPRESSOR by Oricare, Inc. — Product Code BTI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 10, 2012
Date Received
November 14, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type