FDA 510(k) Application Details - K971545

Device Classification Name	Unit, Liquid-Oxygen, Portable   More FDA Info for this Device
510(K) Number	K971545
Device Name	Unit, Liquid-Oxygen, Portable
Applicant	HEALTHDYNE TECHNOLOGIES, INC. 933 WESTERN DR. INDIANAPOLIS, IN 46241 US Other 510(k) Applications for this Company
Contact	JAY HAYES Other 510(k) Applications for this Contact
Regulation Number	868.5655   More FDA Info for this Regulation Number
Classification Product Code	BYJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/28/1997
Decision Date	07/25/1997
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