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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 K022506
Device Name MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM
Applicant
Widemed, Ltd.
Omer Industrial Park, Bldg. 8c
Pob 3002
Omer,  IL 84965
Applicant Contact DAVID SOLOMON
Correspondent
Widemed, Ltd.
Omer Industrial Park, Bldg. 8c
Pob 3002
Omer,  IL 84965
Correspondent Contact DAVID SOLOMON
Regulation Number868.2375
Classification Product Code
MNR  
Date Received07/30/2002
Decision Date 05/15/2003
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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