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510(k) K242125

Elvie Stride 2 by Chiaro Technology, Ltd. — Product Code HGX

K242125 is an FDA 510(k) premarket notification submitted by Chiaro Technology, Ltd. for the device "Elvie Stride 2". The FDA issued a decision of Substantially Equivalent on Sep 27, 2024. The device falls under product code HGX (Pump, Breast, Powered), a Class II device regulated under 21 CFR 884.5160.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 27, 2024
Date Received
Jul 19, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Breast, Powered
Device Class
Class II
Regulation Number
884.5160
Review Panel
OB
Submission Type

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FDA data resources