510(k) K110474

PHILIPS INTELLIVUE TCG10 by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN — Product Code LKD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2011
Date Received
February 18, 2011
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Carbon-Dioxide, Cutaneous
Device Class
Class II
Regulation Number
868.2480
Review Panel
AN
Submission Type