RESPIRONICS SIMPLYCLEAR DEVICE

Percussor, Powered-electric

RESPIRONICS, INC.

The following data is part of a premarket notification filed by Respironics, Inc. with the FDA for Respironics Simplyclear Device.

Pre-market Notification Details

Device IDK122111
510k NumberK122111
Device Name:RESPIRONICS SIMPLYCLEAR DEVICE
ClassificationPercussor, Powered-electric
Applicant RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville,  PA  15146
ContactColleen Witt
CorrespondentColleen Witt
RESPIRONICS, INC. 1740 GOLDEN MILE HIGHWAY Monroeville,  PA  15146
Product CodeBYI  
CFR Regulation Number868.5665 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-07-17
Decision Date2012-12-31
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00606959058477 K122111 000

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