FDA 510(k) Application Details - K111188

Device Classification Name	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph   More FDA Info for this Device
510(K) Number	K111188
Device Name	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant	Roche Diagnostics 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	Sarah Baumann Other 510(k) Applications for this Contact
Regulation Number	862.1120   More FDA Info for this Regulation Number
Classification Product Code	CHL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/27/2011
Decision Date	05/14/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review