ARDO Alyssa

Pump, Breast, Powered

ARDO Medical AG

The following data is part of a premarket notification filed by Ardo Medical Ag with the FDA for Ardo Alyssa.

Pre-market Notification Details

Device IDK212773
510k NumberK212773
Device Name:ARDO Alyssa
ClassificationPump, Breast, Powered
Applicant ARDO Medical AG Gewerbestrasse 19 Unteraegeri,  CH 6314
ContactThomas Schlieper
CorrespondentKristin Zielinski Duggan
Hogan Lovells US LLP 555 Thirteenth Street NW Washington,  DC  20004
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-08-31
Decision Date2022-04-15

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