FDA 510(k) Application Details - K972614

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K972614
Device Name	Generator, Oxygen, Portable
Applicant	HEALTHDYNE TECHNOLOGIES, INC. 1255 KENNESTONE CIR. MARIETTA, GA 30066 US Other 510(k) Applications for this Company
Contact	BETSY CORTELLONI 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	07/14/1997
Decision Date	01/20/1998
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