Class Class II

Tablo Hemodialysis System (PN-0008000, PN-0006000U) (K253412)

K253412 2026-01-26 Traditional
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Description

Tablo Hemodialysis System (PN-0008000, PN-0006000U) by Outset Medical, Inc., an FDA 510(k) cleared gastroenterology, urology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK253412
Clearance Date2026-01-26
Clearance TypeTraditional
Product CodeKDI
Regulation Number876.5860

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