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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
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