510(k) K031411

MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 by Mercury Medical — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2003
Date Received
May 5, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type