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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilatory Effort Recorder
510(k) Number K081861
Device Name HOLTER LX ANALYSIS
Applicant
NORTH EAST MONITORING INC.
80 SHELTON TECHNOLOGY CENTER
SHELTON,  CT  06484
Applicant Contact JOSEPH AZARY
Correspondent
NORTH EAST MONITORING INC.
80 SHELTON TECHNOLOGY CENTER
SHELTON,  CT  06484
Correspondent Contact JOSEPH AZARY
Regulation Number868.2375
Classification Product Code
MNR  
Date Received07/01/2008
Decision Date 12/04/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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