FDA 510(k) Application Details - K980287

Device Classification Name	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia   More FDA Info for this Device
510(K) Number	K980287
Device Name	Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
Applicant	SIEMENS MEDICAL SOLUTIONS USA, INC. 16 ELECTRONICS AVE. DANVERS, MA 01923 US Other 510(k) Applications for this Company
Contact	JACQUELINE E EMERY Other 510(k) Applications for this Contact
Regulation Number	868.2500   More FDA Info for this Regulation Number
Classification Product Code	KLK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/26/1998
Decision Date	08/12/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review