FDA 510(k) Application Details - K212121

Device Classification Name	Chamber, Oxygen, Topical, Extremity   More FDA Info for this Device
510(K) Number	K212121
Device Name	Chamber, Oxygen, Topical, Extremity
Applicant	Vaporox, Inc. 7012 S. Revere Pkwy, Suite 100 Centennial, CO 80112 US Other 510(k) Applications for this Company
Contact	Alan Sage Other 510(k) Applications for this Contact
Regulation Number	878.5650   More FDA Info for this Regulation Number
Classification Product Code	KPJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/07/2021
Decision Date	03/23/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review