MR Conditional CGA 870— 510(k) K162811

Substantially Equivalent

Essex Industries, Inc.

FDA 510(k) clearance K162811 for MR Conditional CGA 870, Substantially Equivalent on 2017-03-02. Applicant: Essex Industries, Inc..

Clearance details

Applicant: Essex Industries, Inc.
Product code: Code CAN
Advisory panel: Anesthesiology
Date received: 2016-10-06
Decision date: 2017-03-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code CAN

product code CAN

Death: 4
Other: 1
Total: 5

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.