FDA 510(k) Application Details - K981047

Device Classification Name	Generator, Oxygen, Portable   More FDA Info for this Device
510(K) Number	K981047
Device Name	Generator, Oxygen, Portable
Applicant	COLORADO MEDTECH, INC. 6175 LONGBOW DR. BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	LOCKETT E WOOD 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	03/20/1998
Decision Date	09/16/1999
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