FDA 510(k) Application Details - K010435

Device Classification Name	More FDA Info for this Device
510(K) Number	K010435
Device Name	PHILIPS BV PULSERA/ENDURA
Applicant	PHILIPS MEDICAL SYSTEMS, INC. VEENPLUIS 4-6 P.O. BOX 10.000 DA BEST 5680 NL Other 510(k) Applications for this Company
Contact	MARCIA JONES Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2001
Decision Date	03/12/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review