Air Next

Spirometer, Diagnostic

NuvoAir AB

The following data is part of a premarket notification filed by Nuvoair Ab with the FDA for Air Next.

Pre-market Notification Details

Device IDK183089
510k NumberK183089
Device Name:Air Next
ClassificationSpirometer, Diagnostic
Applicant NuvoAir AB 17D Riddargatan Stockholm,  SE 11457
ContactMax Ladow
CorrespondentYolanda Smith
Smith Associates 1468 Harwell Ave Crofton,  MD  21114
Product CodeBZG  
CFR Regulation Number868.1840 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-06
Decision Date2020-01-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
17350002630027 K183089 000

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