Electro Flo 6 Airway Clearance System

FDA 510(k) K201490 · Med Systems, Inc.

Substantially Equivalent

510(k) numberK201490

Submission

Device name
Electro Flo 6 Airway Clearance System
Applicant
Med Systems, Inc.
San Diego, CA, US
Received
June 4, 2020
Decision date
February 12, 2021
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
BYI – Percussor, Powered-Electric
Device class
Class II (moderate risk)
Regulation
21 CFR 868.5665
Specialty
Anesthesiology

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Questions and answers

When was Electro Flo 6 Airway Clearance System cleared by the FDA?

Electro Flo 6 Airway Clearance System (K201490) received a 510(k) decision of Substantially Equivalent on February 12, 2021, 253 days after the submission was received.

What is the product code of K201490?

The FDA product code is BYI – Percussor, Powered-Electric, a Class II (moderate risk) device regulated under 21 CFR 868.5665.