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FDA 510(k)

FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE

K-Number: K002410 · 2001-06-06

ApplicantDysphagia, LLC
Decision Date2001-06-06
Product CodeIPF
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Dysphagia, LLC. It received FDA 510(k) clearance on 2001-06-06 under 510(k) number K002410. 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 FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE?

FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE is a medical device that received FDA 510(k) clearance on 2001-06-06. The listed applicant is Dysphagia, LLC. The 510(k) number is K002410.

When did FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE receive FDA 510(k) clearance?

FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE received FDA 510(k) clearance on 2001-06-06, under 510(k) number K002410.

Who is the listed applicant for FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE?

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

What is the FDA product code for FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE?

The FDA product code for FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE is IPF.

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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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