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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 K073269
Device Name HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM
Applicant
HYPNOCORE, LTD.
291 Hillside Avenue
Somerset,  MA  02726
Applicant Contact GEORGE J HATTUB
Correspondent
HYPNOCORE, LTD.
291 Hillside Avenue
Somerset,  MA  02726
Correspondent Contact GEORGE J HATTUB
Regulation Number868.2375
Classification Product Code
MNR  
Date Received11/21/2007
Decision Date 04/18/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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