FDA 510(k) Application Details - K192693

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K192693
Device Name	Generator, Oxygen, Portable
Applicant	Nidek Medical Products, Inc. 3949 Valley East Industrial Drive Brimingham, AL 35217 US Other 510(k) Applications for this Company
Contact	Olivia Mullen 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	09/26/2019
Decision Date	05/07/2020
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