510(k) K130112

CAPNO MODULE, 92517 by Spacelabs Healthcare — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2013
Date Received
January 16, 2013
Clearance Type
Special
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