GOLIFE NASAL MASK

Ventilator, Non-continuous (respirator)

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Golife Nasal Mask.

Pre-market Notification Details

Device IDK102502
510k NumberK102502
Device Name:GOLIFE NASAL MASK
ClassificationVentilator, Non-continuous (respirator)
Applicant RESPIRONICS, INC. 365 PLUM INDUSTRIAL COURT Pittsburgh,  PA  15239
ContactMichelle Brinker
CorrespondentMichelle Brinker
RESPIRONICS, INC. 365 PLUM INDUSTRIAL COURT Pittsburgh,  PA  15239
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-01
Decision Date2010-12-22
Summary:summary

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