510(k) K210782

Tablo Cartridge by Outset Medical, Inc. — Product Code FJK

K210782 is an FDA 510(k) premarket notification submitted by Outset Medical, Inc. for the device "Tablo Cartridge". The FDA issued a decision of Substantially Equivalent on November 26, 2021. The device falls under product code FJK (Set, Tubing, Blood, With And Without Anti-Regurgitation Valve), a Class II device regulated under 21 CFR 876.5820. Outset Medical, Inc. has at least 9 other 510(k) clearances on record.