FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Cedars-Sinai Medical Center: Aim. It received FDA 510(k) clearance on 2023-05-19 under 510(k) 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. The listed applicant is Cedars-Sinai Medical Center: Aim. The 510(k) number is K212758.

When did Autoplaque receive FDA 510(k) clearance?

Autoplaque received FDA 510(k) clearance on 2023-05-19, under 510(k) number K212758.

Who is the listed applicant for Autoplaque?

The FDA 510(k) record lists Cedars-Sinai Medical Center: Aim as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Autoplaque?

The FDA product code for Autoplaque is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.