Electro Flo 6 Airway Clearance System— 510(k) K201490

Substantially Equivalent

Med Systems, Inc.

FDA 510(k) clearance K201490 for Electro Flo 6 Airway Clearance System, Substantially Equivalent on 2021-02-12. Applicant: Med Systems, Inc..

Clearance details

Applicant: Med Systems, Inc.
Product code: Code BYI
Advisory panel: Anesthesiology
Date received: 2020-06-04
Decision date: 2021-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BYI

product code BYI

Death: 3
Total: 3

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.