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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name monitor,physiological,patient(without arrhythmia detection or alarms)
510(k) Number K071606
Device Name BIOSIGN CENTRAL STATION
Original Applicant
OBS MEDICAL
12900 n. meridian st. ste. 120
carmel,  IN  46032
Original Contact wayne nethercutt
Regulation Number870.2300
Classification Product Code
MWI  
Date Received06/12/2007
Decision Date 08/31/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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