FDA 510(k)

Tel-O-Graph

K-Number: K173895 · 2019-05-16

ApplicantI.E.M. Industrielle Entwicklung and Medizintechnik

Decision Date2019-05-16

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Tel-O-Graph is a medical device manufactured by I.E.M. Industrielle Entwicklung and Medizintechnik. It received FDA 510(k) clearance on 2019-05-16 under approval number K173895. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Tel-O-Graph?

Tel-O-Graph is a medical device that received FDA 510(k) clearance on 2019-05-16. It is manufactured by I.E.M. Industrielle Entwicklung and Medizintechnik. The 510(k) number is K173895.

When was Tel-O-Graph approved by the FDA?

Tel-O-Graph received FDA 510(k) clearance on 2019-05-16, under approval number K173895.

What company makes Tel-O-Graph?

Tel-O-Graph is manufactured by I.E.M. Industrielle Entwicklung and Medizintechnik.

What is the FDA product code for Tel-O-Graph?

The FDA product code for Tel-O-Graph is DXN.

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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.