FDA 510(k) Application Details - K182454

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K182454
Device Name	Generator, Oxygen, Portable
Applicant	O2 Concepts LLC 199 Park Road Extension Middlebury, CT 06762 US Other 510(k) Applications for this Company
Contact	Kathryn G. Forgione Other 510(k) Applications for this Contact
Regulation Number	868.5440   More FDA Info for this Regulation Number
Classification Product Code	CAW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/07/2018
Decision Date	12/20/2018
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	Y
Expedited Review