FDA 510(k) Application Details - K992215

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K992215
Device Name	Oximeter
Applicant	ENVITEC-WISMAR GMBH N8259 COTTAGE DR. FOND DU LAC, WI 54937 US Other 510(k) Applications for this Company
Contact	STEPHEN H GORSKI 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	07/01/1999
Decision Date	03/29/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review