Class Class II

Sleepiz One+ (Model 2.5) (K253388)

K253388 2026-01-28 Special
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Description

Sleepiz One+ (Model 2.5) by Sleepiz AG, an FDA 510(k) cleared cardiovascular device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253388
Clearance Date2026-01-28
Clearance TypeSpecial
Product CodeDRT
Regulation Number870.2300

Categories

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