FDA 510(k) Application Details - K082546

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K082546
Device Name	Oximeter
Applicant	UNIMED MEDICAL SUPPLIES INC. W322S8863 MCCARTHY DR. MUKWONAGO, WI 53149 US Other 510(k) Applications for this Company
Contact	DON MELNIKOFF 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	09/03/2008
Decision Date	12/02/2008
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