Chemo Mouthpiece
K-Number: K232917 · 2024-01-23
ApplicantChemo Mouthpiece, LLC
Decision Date2024-01-23
Product CodeQUA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
Chemo Mouthpiece is the device name listed in this FDA 510(k) record. The listed applicant is Chemo Mouthpiece, LLC. It received FDA 510(k) clearance on 2024-01-23 under 510(k) number K232917. The device is classified under product code QUA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Chemo Mouthpiece?
Chemo Mouthpiece is a medical device that received FDA 510(k) clearance on 2024-01-23. The listed applicant is Chemo Mouthpiece, LLC. The 510(k) number is K232917.
When did Chemo Mouthpiece receive FDA 510(k) clearance?
Chemo Mouthpiece received FDA 510(k) clearance on 2024-01-23, under 510(k) number K232917.
Who is the listed applicant for Chemo Mouthpiece?
The FDA 510(k) record lists Chemo Mouthpiece, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Chemo Mouthpiece?
The FDA product code for Chemo Mouthpiece is QUA.
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.