Class Class II

QIKCAP System (DEN250004)

DEN250004 2025-12-23 Direct
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Description

QIKCAP System by Hai Solutions, an FDA 510(k) cleared general hospital device.

Regulatory Information

Device ClassClass Class II
510(k) NumberDEN250004
Clearance Date2025-12-23
Clearance TypeDirect
Product CodeSGX
Regulation Number880.6512

Categories

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