FDA 510(k) Application Details - K100777

Device Classification Name	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph   More FDA Info for this Device
510(K) Number	K100777
Device Name	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant	RADIOMETER MEDICAL APS AKANDEVEJ 21 BRONSHOJ DK-2700 DK Other 510(k) Applications for this Company
Contact	ROWENA JANSSON 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	03/18/2010
Decision Date	12/10/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review