FDA 510(k) Application Details - K984081

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K984081
Device Name	Generator, Oxygen, Portable
Applicant	EMOX 911 CC P.O. BOX 79 SOMERSET WEST 7129 ZA Other 510(k) Applications for this Company
Contact	IVOR DUNCAN 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	11/16/1998
Decision Date	03/17/1999
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