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FDA 510(k)

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On

K-Number: K202096 · 2021-02-02

ApplicantEcoguard, Inc.
Decision Date2021-02-02
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is the device name listed in this FDA 510(k) record. The listed applicant is Ecoguard, Inc.. It received FDA 510(k) clearance on 2021-02-02 under 510(k) number K202096. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On?

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is a medical device that received FDA 510(k) clearance on 2021-02-02. The listed applicant is Ecoguard, Inc.. The 510(k) number is K202096.

When did 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On receive FDA 510(k) clearance?

3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On received FDA 510(k) clearance on 2021-02-02, under 510(k) number K202096.

Who is the listed applicant for 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On?

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

What is the FDA product code for 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On?

The FDA product code for 3-ply EcoGuard B with Earloop, 3-ply EcoGuard B with Tie-On is FXX.

Related Devices (Code: FXX)

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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