PATI (Protector Against Tongue Injury)— 510(k) K221469

Name: FDA 510(k) clearance K221469
Creator: U.S. Food and Drug Administration
Published: 2023-02-22

Substantially Equivalent

Neurovice, LLC

FDA 510(k) clearance K221469 for PATI (Protector Against Tongue Injury), Substantially Equivalent on 2023-02-22. Applicant: Neurovice, LLC. Device class: 2.

Clearance details

Applicant: Neurovice, LLC
Product code: Code JXL
Device class: Class 2
Regulation: 21 CFR 882.5070
Advisory panel: Neurology
Date received: 2022-05-20
Decision date: 2023-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wake Forest, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JXL

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K201309 — ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size Medium2021-06-04
K172978 — SurgeoBite2017-12-22
K150518 — Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm2015-06-29
K050188 — EPIGUARD2005-04-27
K992269 — VENTIL-A ORAL PROTECTOR1999-10-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.