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FDA 510(k)

FREQUENCER MODEL V2X

K-Number: K100749 · 2010-08-31

ApplicantDymedso, Inc.
Decision Date2010-08-31
Product CodeBYI
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FREQUENCER MODEL V2X is the device name listed in this FDA 510(k) record. The listed applicant is Dymedso, Inc.. It received FDA 510(k) clearance on 2010-08-31 under 510(k) number K100749. 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 FREQUENCER MODEL V2X?

FREQUENCER MODEL V2X is a medical device that received FDA 510(k) clearance on 2010-08-31. The listed applicant is Dymedso, Inc.. The 510(k) number is K100749.

When did FREQUENCER MODEL V2X receive FDA 510(k) clearance?

FREQUENCER MODEL V2X received FDA 510(k) clearance on 2010-08-31, under 510(k) number K100749.

Who is the listed applicant for FREQUENCER MODEL V2X?

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

What is the FDA product code for FREQUENCER MODEL V2X?

The FDA product code for FREQUENCER MODEL V2X 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 Dymedso, 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.

K103176FREQUENCERK063645FREQUENCER, MODEL 1001

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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