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FDA 510(k)

SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL

K-Number: K053248 · 2005-12-01

ApplicantElectromed, Inc.
Decision Date2005-12-01
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL is the device name listed in this FDA 510(k) record. The listed applicant is Electromed, Inc.. It received FDA 510(k) clearance on 2005-12-01 under 510(k) number K053248. 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, MODEL TL?

SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL is a medical device that received FDA 510(k) clearance on 2005-12-01. The listed applicant is Electromed, Inc.. The 510(k) number is K053248.

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

SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL received FDA 510(k) clearance on 2005-12-01, under 510(k) number K053248.

Who is the listed applicant for SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL?

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, MODEL TL?

The FDA product code for SMARTVEST AIRWAY CLEARANCE SYSTEM, MODEL TL 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 SystemK132794SMARTVEST AIRWAY CLEARANCE SYSTEMK040367MEDPULSE 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

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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