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510(k) K223812

Sensis Vibe (VD15) by Siemens Medical Solutions USA, Inc. — Product Code DQK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 15, 2023
Date Received
December 20, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Computer, Diagnostic, Programmable
Device Class
Class II
Regulation Number
870.1425
Review Panel
CV
Submission Type

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  • K251591 — Holter ECG and ABP system (HolterABP) (February 9, 2026)
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  • K254085 — CARTO™ 3 EP Navigation System V9.0 with PIU Plus (January 18, 2026)
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