Outset Medical, Inc.
Tablo Hemodialysis System (PN-0008000, PN-0006000U)
SKU K253412UPC KDI
In Stock
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IIFDA 510(k) Cleared (K253412)
1
Free shipping on orders over $99 · 30-day returns
Outset Medical, Inc.
Free shipping on orders over $99 · 30-day returns
Tablo Hemodialysis System (PN-0008000, PN-0006000U) is an FDA 510(k)-cleared medical device (K253412) manufactured by Outset Medical, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 25, 2026. Regulation: 8.
