CNS Envision— 510(k) K192572

Substantially Equivalent

Moberg Research, Inc.

FDA 510(k) clearance K192572 for CNS Envision, Substantially Equivalent on 2019-12-17. Applicant: Moberg Research, Inc..

Clearance details

Applicant: Moberg Research, Inc.
Product code: Code OLT
Advisory panel: Neurology
Date received: 2019-09-18
Decision date: 2019-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ambler, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OLT

product code OLT

Other: 1
Total: 1

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.