Tablo Cartridge
K-Number: K210782 · 2021-11-26
ApplicantOutset Medical, Inc.
Decision Date2021-11-26
Product CodeFJK
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Tablo Cartridge is a medical device manufactured by Outset Medical, Inc.. It received FDA 510(k) clearance on 2021-11-26 under approval number K210782. The device is classified under product code FJK. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tablo Cartridge?
Tablo Cartridge is a medical device that received FDA 510(k) clearance on 2021-11-26. It is manufactured by Outset Medical, Inc.. The 510(k) number is K210782.
When was Tablo Cartridge approved by the FDA?
Tablo Cartridge received FDA 510(k) clearance on 2021-11-26, under approval number K210782.
What company makes Tablo Cartridge?
Tablo Cartridge is manufactured by Outset Medical, Inc..
What is the FDA product code for Tablo Cartridge?
The FDA product code for Tablo Cartridge is FJK.
Other Devices by Outset Medical, Inc.
Related Devices (Code: FJK)
K150304Oxyless Blood Tubing SetOxyless, Ltd.
K161582DORA Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd.
K171952Dimesol Tubing Sets for HemodialysisDimesol, Inc.
K202796SANSIN Tubing Sets for HemodialysisJiangxi Sanxin Medtec Co., Ltd.
K201866NovaLine Tubing Sets for HemodialysisBain Medical Equipment (Guangzhou) Co., Ltd.
K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.