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FDA 510(k)

ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT

K-Number: K092202 · 2011-02-10

ApplicantEswallow USA
Decision Date2011-02-10
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Eswallow USA. It received FDA 510(k) clearance on 2011-02-10 under 510(k) number K092202. The device is classified under product code IPF. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT?

ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT is a medical device that received FDA 510(k) clearance on 2011-02-10. The listed applicant is Eswallow USA. The 510(k) number is K092202.

When did ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT receive FDA 510(k) clearance?

ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT received FDA 510(k) clearance on 2011-02-10, under 510(k) number K092202.

Who is the listed applicant for ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT?

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

What is the FDA product code for ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT?

The FDA product code for ESWALLOW DYSPHAGIA THERAPY KIT, PMI DYSPHAGIA THERAPY KIT is IPF.

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 Eswallow USA 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.

K113375ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE

Related Devices (Code: IPF)

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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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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