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FDA 510(k)

Electromed SmartVest Airway Clearance System

K-Number: K222496 · 2022-11-18

ApplicantElectromed, Inc.
Decision Date2022-11-18
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Electromed SmartVest Airway Clearance System is a medical device manufactured by Electromed, Inc.. It received FDA 510(k) clearance on 2022-11-18 under approval number K222496. 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 Electromed SmartVest Airway Clearance System?

Electromed SmartVest Airway Clearance System is a medical device that received FDA 510(k) clearance on 2022-11-18. It is manufactured by Electromed, Inc.. The 510(k) number is K222496.

When was Electromed SmartVest Airway Clearance System approved by the FDA?

Electromed SmartVest Airway Clearance System received FDA 510(k) clearance on 2022-11-18, under approval number K222496.

What company makes Electromed SmartVest Airway Clearance System?

Electromed SmartVest Airway Clearance System is manufactured by Electromed, Inc..

What is the FDA product code for Electromed SmartVest Airway Clearance System?

The FDA product code for Electromed SmartVest 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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