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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 K960925
Device Name NORTHEAST MONITORING DR180
Applicant
North East Monitoring, Inc.
730 Boston Post Rd., Suite 22
Sudbury,  MA  01776
Applicant Contact MARK HUBELBANK
Correspondent
North East Monitoring, Inc.
730 Boston Post Rd., Suite 22
Sudbury,  MA  01776
Correspondent Contact MARK HUBELBANK
Regulation Number870.2800
Classification Product Code
DSH  
Date Received03/06/1996
Decision Date 07/31/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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