FDA 510(k) Application Details - K171129

Device Classification Name	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K171129
Device Name	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Applicant	MD Diagnostics Limited 15 Hollingworth Court, Turkey Mill Maidstone ME14 5pp GB Other 510(k) Applications for this Company
Contact	Glen Hillsley Other 510(k) Applications for this Contact
Regulation Number	868.1430   More FDA Info for this Regulation Number
Classification Product Code	CCJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/17/2017
Decision Date	03/02/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review