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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 the device name listed in this FDA 510(k) record. The listed applicant is I.E.M. Industrielle Entwicklung and Medizintechnik. It received FDA 510(k) clearance on 2019-05-16 under 510(k) 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. The listed applicant is I.E.M. Industrielle Entwicklung and Medizintechnik. The 510(k) number is K173895.

When did Tel-O-Graph receive FDA 510(k) clearance?

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

Who is the listed applicant for Tel-O-Graph?

The FDA 510(k) record lists I.E.M. Industrielle Entwicklung and Medizintechnik as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: DXN)

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.

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