FDA 510(k) Application Details - K110953

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K110953
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	OBS MEDICAL ROSEMARY HOUSE 31 CHURCH GREEN STANFORD IN THE VALE OXFORD SN7 8HU GB Other 510(k) Applications for this Company
Contact	CHRIS WEATHERALL Other 510(k) Applications for this Contact
Regulation Number	870.1025   More FDA Info for this Regulation Number
Classification Product Code	MHX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/05/2011
Decision Date	06/15/2011
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review