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FDA 510(k)

ClariSIGMAM

K-Number: K203785 · 2021-09-10

ApplicantClaripi, Inc.
Decision Date2021-09-10
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ClariSIGMAM is a medical device manufactured by Claripi, Inc.. It received FDA 510(k) clearance on 2021-09-10 under approval number K203785. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClariSIGMAM?

ClariSIGMAM is a medical device that received FDA 510(k) clearance on 2021-09-10. It is manufactured by Claripi, Inc.. The 510(k) number is K203785.

When was ClariSIGMAM approved by the FDA?

ClariSIGMAM received FDA 510(k) clearance on 2021-09-10, under approval number K203785.

What company makes ClariSIGMAM?

ClariSIGMAM is manufactured by Claripi, Inc..

What is the FDA product code for ClariSIGMAM?

The FDA product code for ClariSIGMAM is QIH.

Other Devices by Claripi, Inc.

K183460ClariCT.AI K212074ClariCT.AI K203783ClariPulmo

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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.

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