FDA 510(k) Application Details - K071397

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K071397
Device Name	Generator, Oxygen, Portable
Applicant	SUNRISE MEDICAL 100 DEVILBISS DR. SOMERSET, PA 15501 US Other 510(k) Applications for this Company
Contact	JOSEPH E OLSAVSKY 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	05/21/2007
Decision Date	10/01/2007
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