Class Class II

CardioVision (K251293)

K251293 2025-11-21 Traditional
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Description

CardioVision by Icardio.Ai, an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK251293
Clearance Date2025-11-21
Clearance TypeTraditional
Product CodeQUO
Regulation Number870.2200

Categories

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