510(k) K072348

PRECISION OXYGEN CONCENTRATOR by Precision Medical, Inc. — Product Code CAW

K072348 is an FDA 510(k) premarket notification submitted by Precision Medical, Inc. for the device "PRECISION OXYGEN CONCENTRATOR". The FDA issued a decision of Substantially Equivalent on October 27, 2008. The device falls under product code CAW (Generator, Oxygen, Portable), a Class II device regulated under 21 CFR 868.5440. Precision Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 2008
Date Received
August 21, 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