Tec 820, Tec 850— 510(k) K172702

Substantially Equivalent

Datex-Ohmeda, Inc.

FDA 510(k) clearance K172702 for Tec 820, Tec 850, Substantially Equivalent on 2018-01-04. Applicant: Datex-Ohmeda, Inc..

Clearance details

Applicant: Datex-Ohmeda, Inc.
Product code: Code CAD
Advisory panel: Anesthesiology
Date received: 2017-09-07
Decision date: 2018-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madison, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAD

product code CAD

Malfunction: 3,275
Total: 3,275

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.