Tellos ISQ Buddy
K-Number: K143445 · 2016-01-07
ApplicantTellos Medical AB
Decision Date2016-01-07
Product CodeEKX
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Tellos ISQ Buddy is a medical device manufactured by Tellos Medical AB. It received FDA 510(k) clearance on 2016-01-07 under approval number K143445. The device is classified under product code EKX. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tellos ISQ Buddy?
Tellos ISQ Buddy is a medical device that received FDA 510(k) clearance on 2016-01-07. It is manufactured by Tellos Medical AB. The 510(k) number is K143445.
When was Tellos ISQ Buddy approved by the FDA?
Tellos ISQ Buddy received FDA 510(k) clearance on 2016-01-07, under approval number K143445.
What company makes Tellos ISQ Buddy?
Tellos ISQ Buddy is manufactured by Tellos Medical AB.
What is the FDA product code for Tellos ISQ Buddy?
The FDA product code for Tellos ISQ Buddy is EKX.
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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.