Tablo Console
K-Number: K160881 · 2016-11-15
ApplicantOutset Medical, Inc.
Decision Date2016-11-15
Product CodeKDI
Advisory CommitteeGU
DecisionSubstantially Equivalent
Device Summary
Tablo Console is a medical device manufactured by Outset Medical, Inc.. It received FDA 510(k) clearance on 2016-11-15 under approval number K160881. The device is classified under product code KDI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tablo Console?
Tablo Console is a medical device that received FDA 510(k) clearance on 2016-11-15. It is manufactured by Outset Medical, Inc.. The 510(k) number is K160881.
When was Tablo Console approved by the FDA?
Tablo Console received FDA 510(k) clearance on 2016-11-15, under approval number K160881.
What company makes Tablo Console?
Tablo Console is manufactured by Outset Medical, Inc..
What is the FDA product code for Tablo Console?
The FDA product code for Tablo Console is KDI.
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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.