510(k) K072131

M3 MONITOR by Spectrum Medical , Ltd. — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 2007
Date Received
August 2, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4330
Review Panel
CV
Submission Type