FDA 510(k) Application Details - K100077

Device Classification Name	Oximeter   More FDA Info for this Device
510(K) Number	K100077
Device Name	Oximeter
Applicant	SOLARIS MEDICAL TECHNOLOGY, INC. 400 OYSTER POINT BLVD. SUITE 534 SOUTH SAN FRANCISCO, CA 94080 US Other 510(k) Applications for this Company
Contact	RACHEL CHENG 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	01/12/2010
Decision Date	10/07/2010
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