NOA Sleep Apnea And Snoring Device

Device, Anti-snoring

Orthoapnea S.L.

The following data is part of a premarket notification filed by Orthoapnea S.l. with the FDA for Noa Sleep Apnea And Snoring Device.

Pre-market Notification Details

Device IDK202651
510k NumberK202651
Device Name:NOA Sleep Apnea And Snoring Device
ClassificationDevice, Anti-snoring
Applicant Orthoapnea S.L. C / Flauta Magica 22 Malaga,  ES 29006
ContactJose Repolles Llecha
CorrespondentJose Repolles Llecha
Orthoapnea S.L. C / Flauta Magica 22 Malaga,  ES 29006
Product CodeLRK  
CFR Regulation Number872.5570 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-14
Decision Date2021-02-12

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