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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Continuous Measurement Thermometer
510(k) Number K983576
Device Name DR180-R/OXY
Applicant
North East Monitoring, Inc.
730 Boston Post Rd., Suite 22
Sudbury,  MA  01776
Applicant Contact RODNEY L CAMBRE
Correspondent
North East Monitoring, Inc.
730 Boston Post Rd., Suite 22
Sudbury,  MA  01776
Correspondent Contact RODNEY L CAMBRE
Regulation Number880.2910
Classification Product Code
FLL  
Date Received10/13/1998
Decision Date 03/23/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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