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FDA 510(k)

Electro Flo 6 Airway Clearance System

K-Number: K201490 · 2021-02-12

ApplicantMed Systems, Inc.
Decision Date2021-02-12
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Electro Flo 6 Airway Clearance System is a medical device manufactured by Med Systems, Inc.. It received FDA 510(k) clearance on 2021-02-12 under approval number K201490. The device is classified under product code BYI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Electro Flo 6 Airway Clearance System?

Electro Flo 6 Airway Clearance System is a medical device that received FDA 510(k) clearance on 2021-02-12. It is manufactured by Med Systems, Inc.. The 510(k) number is K201490.

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

Electro Flo 6 Airway Clearance System received FDA 510(k) clearance on 2021-02-12, under approval number K201490.

What company makes Electro Flo 6 Airway Clearance System?

Electro Flo 6 Airway Clearance System is manufactured by Med Systems, Inc..

What is the FDA product code for Electro Flo 6 Airway Clearance System?

The FDA product code for Electro Flo 6 Airway Clearance System is BYI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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