PERFORMAX TOTAL FACE MASK

Ventilator, Non-continuous (respirator)

RESPIRONICS, INC.

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

Pre-market Notification Details

Device IDK103395
510k NumberK103395
Device Name:PERFORMAX TOTAL FACE 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 Received2010-11-19
Decision Date2011-03-24
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30606959007858 K103395 000
30606959041845 K103395 000
30606959024718 K103395 000

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