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FDA 510(k)

PulmoScan

K-Number: K191876 · 2020-03-18

ApplicantCognita Labs, LLC
Decision Date2020-03-18
Product CodePNV
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PulmoScan is a medical device manufactured by Cognita Labs, LLC. It received FDA 510(k) clearance on 2020-03-18 under approval number K191876. The device is classified under product code PNV. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PulmoScan?

PulmoScan is a medical device that received FDA 510(k) clearance on 2020-03-18. It is manufactured by Cognita Labs, LLC. The 510(k) number is K191876.

When was PulmoScan approved by the FDA?

PulmoScan received FDA 510(k) clearance on 2020-03-18, under approval number K191876.

What company makes PulmoScan?

PulmoScan is manufactured by Cognita Labs, LLC.

What is the FDA product code for PulmoScan?

The FDA product code for PulmoScan is PNV.

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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