PERFORMAX PEDIATRIC EE 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 Pediatric Ee Total Face Mask.

Pre-market Notification Details

Device IDK120562
510k NumberK120562
Device Name:PERFORMAX PEDIATRIC EE 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)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-02-24
Decision Date2012-07-17
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30606959014535 K120562 000
30606959014511 K120562 000
30606959013590 K120562 000
30606959013576 K120562 000
30606959012470 K120562 000
00606959008045 K120562 000
00606959008038 K120562 000
30606959007742 K120562 000
30606959007735 K120562 000

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