FDA 510(k) Application Details - K123738

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K123738
Device Name	Generator, Oxygen, Portable
Applicant	NIDEK MEDICAL PRODUCTS, INC. 3949 VALLEY EAST INDUSTRIAL DR BIRMINGHAM, AL 35217 US Other 510(k) Applications for this Company
Contact	VAN MUTH 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	12/05/2012
Decision Date	02/28/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review