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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(With Arrhythmia Detection Or Alarms)
510(k) Number K081140
Device Name VISENSIA
Applicant
OBS MEDICAL
11495 PENNSYLVANIA ST. STE.
250
CARMEL,  IN  46032
Applicant Contact WAYNE NETHERCUTT
Correspondent
OBS MEDICAL
11495 PENNSYLVANIA ST. STE.
250
CARMEL,  IN  46032
Correspondent Contact WAYNE NETHERCUTT
Regulation Number870.1025
Classification Product Code
MHX  
Date Received04/22/2008
Decision Date 07/17/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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