PURITAN-BENNETT NASAL CPAP MASK

Attachment, Breathing, Positive End Expiratory Pressure

PURITAN-BENNETT

The following data is part of a premarket notification filed by Puritan-bennett with the FDA for Puritan-bennett Nasal Cpap Mask.

Pre-market Notification Details

Device IDK942246
510k NumberK942246
Device Name:PURITAN-BENNETT NASAL CPAP MASK
ClassificationAttachment, Breathing, Positive End Expiratory Pressure
Applicant PURITAN-BENNETT 10800 PFLUMM RD. Lenexa,,  KS  66215
ContactMarshall C Smith
CorrespondentMarshall C Smith
PURITAN-BENNETT 10800 PFLUMM RD. Lenexa,,  KS  66215
Product CodeBYE  
CFR Regulation Number868.5965 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-09
Decision Date1994-07-06

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