FDA 510(k) Application Details - K022196

Device Classification Name	Unit, Neonatal Phototherapy   More FDA Info for this Device
510(K) Number	K022196
Device Name	Unit, Neonatal Phototherapy
Applicant	NATUS MEDICAL, INC. 1501 INDUSTRIAL RD. SAN CARLOS, CA 94070 US Other 510(k) Applications for this Company
Contact	SHEILA RAMERMAN Other 510(k) Applications for this Contact
Regulation Number	880.5700   More FDA Info for this Regulation Number
Classification Product Code	LBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/05/2002
Decision Date	09/19/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review