510(k) K952268

MODEL DELTA, OM OXYGEN CONCENTRATOR by Caire, Inc. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 11, 1995
Date Received
May 15, 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