FDA 510(k) Application Details - K983777

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K983777
Device Name	Generator, Oxygen, Portable
Applicant	INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 ELYRIA, OH 44036 US Other 510(k) Applications for this Company
Contact	EDWARD A KROLL 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	10/26/1998
Decision Date	12/18/1998
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