FDA 510(k) Application Details - K093308

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K093308
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	JENNIFER MCWILLIAMS 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	10/22/2009
Decision Date	01/14/2010
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review