510(k) K063096

PRECISION OXYGEN MONITOR by Precision Medical, Inc. — Product Code CCL

K063096 is an FDA 510(k) premarket notification submitted by Precision Medical, Inc. for the device "PRECISION OXYGEN MONITOR". The FDA issued a decision of Substantially Equivalent on February 27, 2007. The device falls under product code CCL (Analyzer, Gas, Oxygen, Gaseous-Phase), a Class II device regulated under 21 CFR 868.1720. Precision Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2007
Date Received
October 10, 2006
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Oxygen, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1720
Review Panel
AN
Submission Type