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FDA 510(k)

SMARTVEST AIRWAY CLEARANCE SYSTEM

K-Number: K132794 · 2013-12-19

ApplicantElectromed, Inc.
Decision Date2013-12-19
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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 2013-12-19 under 510(k) number K132794. 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 SMARTVEST AIRWAY CLEARANCE SYSTEM?

SMARTVEST AIRWAY CLEARANCE SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-19. The listed applicant is Electromed, Inc.. The 510(k) number is K132794.

When did SMARTVEST AIRWAY CLEARANCE SYSTEM receive FDA 510(k) clearance?

SMARTVEST AIRWAY CLEARANCE SYSTEM received FDA 510(k) clearance on 2013-12-19, under 510(k) number K132794.

Who is the listed applicant for 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 SMARTVEST AIRWAY CLEARANCE SYSTEM?

The FDA product code for SMARTVEST AIRWAY CLEARANCE SYSTEM is BYI.

Related Clinical Trials

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.

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Other records listing Electromed, Inc. as applicant

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.

K222496Electromed SmartVest Airway Clearance SystemK053248SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TLK040367MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 2000EZK982889MEDPULSE RESPIRATORY VEST SYSTEM, MODEL 1000

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 CorportationK222496Electromed SmartVest Airway Clearance SystemElectromed, 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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