510(k) K951882

ECO CHECK (ECOVALVE AND OXYGEN MONITOR) by Airsep Corp. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 1995
Date Received
April 3, 1995
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