FDA 510(k) Application Details - K981655

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K981655
Device Name	Oximeter
Applicant	SPACELABS MEDICAL, INC. P.O. BOX 97013 REDMOND, WA 98073-9713 US Other 510(k) Applications for this Company
Contact	NANCY GERTLAR Other 510(k) Applications for this Contact
Regulation Number	870.2700   More FDA Info for this Regulation Number
Classification Product Code	DQA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/1998
Decision Date	12/03/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review