Tel-O-Graph— 510(k) K173895

Substantially Equivalent

I.E.M. Industrielle Entwicklung and Medizintechnik

FDA 510(k) clearance K173895 for Tel-O-Graph, Substantially Equivalent on 2019-05-16. Applicant: I.E.M. Industrielle Entwicklung and Medizintechnik.

Clearance details

Applicant: I.E.M. Industrielle Entwicklung and Medizintechnik
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2017-12-21
Decision date: 2019-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stolberg, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.