FDA 510(k) Application Details - K081140

Device Classification Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)   More FDA Info for this Device
510(K) Number	K081140
Device Name	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
Applicant	OBS MEDICAL 11495 PENNSYLVANIA ST. STE. 250 CARMEL, IN 46032 US Other 510(k) Applications for this Company
Contact	WAYNE NETHERCUTT 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	04/22/2008
Decision Date	07/17/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review