FDA 510(k) Application Details - K151978

Device Classification Name	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph   More FDA Info for this Device
510(K) Number	K151978
Device Name	Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
Applicant	EDAN INSTRUMENTS, INC. 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK, #1019 NANHAI ROAD SHENZHEN 518067 CN Other 510(k) Applications for this Company
Contact	TRACY YUE 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	07/17/2015
Decision Date	07/15/2016
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