510(k) K072688

LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000 by International Biophysics Corp. — Product Code CAW

K072688 is an FDA 510(k) premarket notification submitted by International Biophysics Corp. for the device "LIFECHOICE OXYGEN CONCENTRATOR, MODEL OXY1000". The FDA issued a decision of Substantially Equivalent on January 11, 2008. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. International Biophysics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 11, 2008
Date Received
September 24, 2007
Clearance Type
Abbreviated
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