FDA 510(k)

PATI (Protector Against Tongue Injury)

K-Number: K221469 · 2023-02-22

Decision Date2023-02-22

Product CodeJXL

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PATI (Protector Against Tongue Injury) is the device name listed in this FDA 510(k) record. The listed applicant is Neurovice, LLC. It received FDA 510(k) clearance on 2023-02-22 under 510(k) number K221469. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATI (Protector Against Tongue Injury)?

PATI (Protector Against Tongue Injury) is a medical device that received FDA 510(k) clearance on 2023-02-22. The listed applicant is Neurovice, LLC. The 510(k) number is K221469.

When did PATI (Protector Against Tongue Injury) receive FDA 510(k) clearance?

PATI (Protector Against Tongue Injury) received FDA 510(k) clearance on 2023-02-22, under 510(k) number K221469.

Who is the listed applicant for PATI (Protector Against Tongue Injury)?

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

What is the FDA product code for PATI (Protector Against Tongue Injury)?

The FDA product code for PATI (Protector Against Tongue Injury) is JXL.

Related Devices (Code: JXL)

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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.