Autoplaque
K-Number: K212758 · 2023-05-19
ApplicantCedars-Sinai Medical Center: Aim
Decision Date2023-05-19
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Autoplaque is a medical device manufactured by Cedars-Sinai Medical Center: Aim. It received FDA 510(k) clearance on 2023-05-19 under approval number K212758. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Autoplaque?
Autoplaque is a medical device that received FDA 510(k) clearance on 2023-05-19. It is manufactured by Cedars-Sinai Medical Center: Aim. The 510(k) number is K212758.
When was Autoplaque approved by the FDA?
Autoplaque received FDA 510(k) clearance on 2023-05-19, under approval number K212758.
What company makes Autoplaque?
Autoplaque is manufactured by Cedars-Sinai Medical Center: Aim.
What is the FDA product code for Autoplaque?
The FDA product code for Autoplaque is LLZ.
Related Devices (Code: LLZ)
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.