MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM

Ventilatory Effort Recorder

NELLCOR PURITAN BENNETT (MELVILLE) LTD.

The following data is part of a premarket notification filed by Nellcor Puritan Bennett (melville) Ltd. with the FDA for Modification To Suzanne Portable Polysomnograph System.

Pre-market Notification Details

Device IDK030611
510k NumberK030611
Device Name:MODIFICATION TO SUZANNE PORTABLE POLYSOMNOGRAPH SYSTEM
ClassificationVentilatory Effort Recorder
Applicant NELLCOR PURITAN BENNETT (MELVILLE) LTD. 400-303 TERRY FOX DR. Kanata, Ontario,  CA K2k 3j1
ContactRob Matheson
CorrespondentRob Matheson
NELLCOR PURITAN BENNETT (MELVILLE) LTD. 400-303 TERRY FOX DR. Kanata, Ontario,  CA K2k 3j1
Product CodeMNR  
CFR Regulation Number868.2375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-26
Decision Date2003-03-24
Summary:summary

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