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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K130288
FOIA Releasable 510(k) K130288
Device Name STEALTH MONITOR, STEALTH DOCKING CABLE, STEALTH DISPLAY AND STORAGE DEVICE
Applicant
Cardiac Insight, Inc.
5672 Flagler Rd.
Nordland,  WA  98358
Applicant Contact DEBORAH SHEFFIELD
Correspondent
Cardiac Insight, Inc.
5672 Flagler Rd.
Nordland,  WA  98358
Correspondent Contact DEBORAH SHEFFIELD
Regulation Number870.2800
Classification Product Code
DSH  
Date Received02/05/2013
Decision Date 05/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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