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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 K030611
FOIA Releasable 510(k) K030611
Device Name MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
Applicant
Nellcor Puritan Bennett (Melville) , Ltd.
400-303 Terry Fox Dr.
Kanata, Ontario,  CA K2K 3J1
Applicant Contact Rob Matheson
Correspondent
Nellcor Puritan Bennett (Melville) , Ltd.
400-303 Terry Fox Dr.
Kanata, Ontario,  CA K2K 3J1
Correspondent Contact Rob Matheson
Regulation Number868.2375
Classification Product Code
MNR  
Date Received02/26/2003
Decision Date 03/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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