FDA 510(k)

CariCloud

K-Number: K200274 · 2020-05-21

Decision Date2020-05-21

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

CariCloud is the device name listed in this FDA 510(k) record. The listed applicant is Caristo Diagnostics. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K200274. 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 CariCloud?

CariCloud is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is Caristo Diagnostics. The 510(k) number is K200274.

When did CariCloud receive FDA 510(k) clearance?

CariCloud received FDA 510(k) clearance on 2020-05-21, under 510(k) number K200274.

Who is the listed applicant for CariCloud?

The FDA 510(k) record lists Caristo Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CariCloud?

The FDA product code for CariCloud is LLZ.

Other records listing Caristo Diagnostics as applicant

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.