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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 K964494
Device Name SLEEPWIZARD
Applicant
Nellcor Puritan Bennett, Inc.
10200 Valley View Rd.
Eden Prairie,  MN  55344
Applicant Contact CHRIS HADLAND
Correspondent
Nellcor Puritan Bennett, Inc.
10200 Valley View Rd.
Eden Prairie,  MN  55344
Correspondent Contact CHRIS HADLAND
Regulation Number868.2375
Classification Product Code
MNR  
Date Received11/08/1996
Decision Date 02/04/1997
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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