IMASK, MODELS 100, 200 AND 300

Ventilator, Non-continuous (respirator)

VITAL SIGNS COLORADO, INC.

The following data is part of a premarket notification filed by Vital Signs Colorado, Inc. with the FDA for Imask, Models 100, 200 And 300.

Pre-market Notification Details

Device IDK051559
510k NumberK051559
Device Name:IMASK, MODELS 100, 200 AND 300
ClassificationVentilator, Non-continuous (respirator)
Applicant VITAL SIGNS COLORADO, INC. 11039 EAST LANSING CIR. Englewood,  CO  80112
ContactTom Dielmann
CorrespondentTom Dielmann
VITAL SIGNS COLORADO, INC. 11039 EAST LANSING CIR. Englewood,  CO  80112
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-13
Decision Date2005-07-08

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