Elvie Stride

Pump, Breast, Powered

Chiaro Technology Limited

The following data is part of a premarket notification filed by Chiaro Technology Limited with the FDA for Elvie Stride.

Pre-market Notification Details

Device IDK210936
510k NumberK210936
Device Name:Elvie Stride
ClassificationPump, Breast, Powered
Applicant Chiaro Technology Limited 2nd Floor 63-66 Hatton Garden London,  GB Ec1n 8le
ContactCarre King
CorrespondentMarc C. Sanchez
Contract In-House Counsel And Consultants, LLC d/b/a FDA Atty 53516 Bickett Chapel Hill,  NC  27517
Product CodeHGX  
CFR Regulation Number884.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-29
Decision Date2021-08-25

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05060442520615 K210936 000

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