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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 the device name listed in this FDA 510(k) record. The listed applicant is Electromed, Inc.. It received FDA 510(k) clearance on 2022-11-18 under 510(k) 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. The listed applicant is Electromed, Inc.. The 510(k) number is K222496.

When did Electromed SmartVest Airway Clearance System receive FDA 510(k) clearance?

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

Who is the listed applicant for Electromed SmartVest Airway Clearance System?

The FDA 510(k) record lists Electromed, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Electromed SmartVest Airway Clearance System is BYI.

Related Devices (Code: BYI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252849AffloVest® Mobile Airway Clearance TherapyTactile MedicalK250860BreatheBand® (Model 1000)Exemplar Medical, LLCK242063LibAirty Airway Clearance SystemSynchrony Medical , Ltd.K240959Respiratory Muscle TrainerChongqing Moffy Innovation Technology Co., Ltd.K233441The Vest APX System (PVAPX1)Baxter Healthcare CorportationK201490Electro Flo 6 Airway Clearance SystemMed Systems, Inc.

Official Source

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

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