FDA 510(k) Application Details - K211918

Device Classification Name	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase   More FDA Info for this Device
510(K) Number	K211918
Device Name	Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Applicant	Bedfont Scientific Ltd Station Road, Harrietsham Maidstone ME17 1JA GB Other 510(k) Applications for this Company
Contact	Louise Bateman 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	06/21/2021
Decision Date	12/21/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review