FDA 510(k) Application Details - K151856

Device Classification Name	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph   More FDA Info for this Device
510(K) Number	K151856
Device Name	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant	SENDX MEDICAL INC. 1945 PALOMAR OAKS WAY CARLSBAD, CA 92011 US Other 510(k) Applications for this Company
Contact	Vibeke Agerlin 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	07/08/2015
Decision Date	08/06/2015
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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