FDA 510(k)

Tellos ISQ Buddy

K-Number: K143445 · 2016-01-07

Decision Date2016-01-07

Product CodeEKX

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Tellos ISQ Buddy is the device name listed in this FDA 510(k) record. The listed applicant is Tellos Medical AB. It received FDA 510(k) clearance on 2016-01-07 under 510(k) 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. The listed applicant is Tellos Medical AB. The 510(k) number is K143445.

When did Tellos ISQ Buddy receive FDA 510(k) clearance?

Tellos ISQ Buddy received FDA 510(k) clearance on 2016-01-07, under 510(k) number K143445.

Who is the listed applicant for Tellos ISQ Buddy?

The FDA 510(k) record lists Tellos Medical AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tellos ISQ Buddy?

The FDA product code for Tellos ISQ Buddy is EKX.

Related Devices (Code: EKX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.