PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US

Ventilator, Non-continuous (respirator)

TYCO HEALTHCARE NANCY

The following data is part of a premarket notification filed by Tyco Healthcare Nancy with the FDA for Puritan Bennett, Goodknight 420 Evolution, Model M-113903-us.

Pre-market Notification Details

Device IDK031470
510k NumberK031470
Device Name:PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US
ClassificationVentilator, Non-continuous (respirator)
Applicant TYCO HEALTHCARE NANCY NELLCOR PURITAN BENNETT DIV. 4280 HACIENDA DRIVE Pleasanton,  CA  94588
ContactJames Bonds
CorrespondentJames Bonds
TYCO HEALTHCARE NANCY NELLCOR PURITAN BENNETT DIV. 4280 HACIENDA DRIVE Pleasanton,  CA  94588
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-05-09
Decision Date2003-06-05
Summary:summary

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