PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST

Ventilator, Non-continuous (respirator)

MALLINCKRODT DEVELOPPEMENT FRANCE

The following data is part of a premarket notification filed by Mallinckrodt Developpement France with the FDA for Puritan Bennett, Sandman Duo And Sandman Duo St.

Pre-market Notification Details

Device IDK082237
510k NumberK082237
Device Name:PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST
ClassificationVentilator, Non-continuous (respirator)
Applicant MALLINCKRODT DEVELOPPEMENT FRANCE 6135 GUNBARREL AVE. Boulder,  CO  80301
ContactTina Dreiling
CorrespondentTina Dreiling
MALLINCKRODT DEVELOPPEMENT FRANCE 6135 GUNBARREL AVE. Boulder,  CO  80301
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-08-07
Decision Date2008-10-09
Summary:summary

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