FDA 510(k) Application Details - K203086

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K203086
Device Name	Generator, Oxygen, Portable
Applicant	Belluscura LLC 5504 Democracy Dr, Suite 200 Plano, TX 75024 US Other 510(k) Applications for this Company
Contact	Sarah Clark 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	10/13/2020
Decision Date	03/02/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review