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FDA 510(k)

CapMedic

K-Number: K183586 · 2019-09-13

ApplicantCognita Labs, LLC
Decision Date2019-09-13
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CapMedic is a medical device manufactured by Cognita Labs, LLC. It received FDA 510(k) clearance on 2019-09-13 under approval number K183586. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CapMedic?

CapMedic is a medical device that received FDA 510(k) clearance on 2019-09-13. It is manufactured by Cognita Labs, LLC. The 510(k) number is K183586.

When was CapMedic approved by the FDA?

CapMedic received FDA 510(k) clearance on 2019-09-13, under approval number K183586.

What company makes CapMedic?

CapMedic is manufactured by Cognita Labs, LLC.

What is the FDA product code for CapMedic?

The FDA product code for CapMedic is CAF.

Other Devices by Cognita Labs, LLC

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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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