PATI (Protector Against Tongue Injury)
K-Number: K221469 · 2023-02-22
ApplicantNeurovice, LLC
Decision Date2023-02-22
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
PATI (Protector Against Tongue Injury) is a medical device manufactured by Neurovice, LLC. It received FDA 510(k) clearance on 2023-02-22 under approval 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. It is manufactured by Neurovice, LLC. The 510(k) number is K221469.
When was PATI (Protector Against Tongue Injury) approved by the FDA?
PATI (Protector Against Tongue Injury) received FDA 510(k) clearance on 2023-02-22, under approval number K221469.
What company makes PATI (Protector Against Tongue Injury)?
PATI (Protector Against Tongue Injury) is manufactured by Neurovice, LLC.
What is the FDA product code for PATI (Protector Against Tongue Injury)?
The FDA product code for PATI (Protector Against Tongue Injury) is JXL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.