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FDA 510(k)

ComPAS2

K-Number: K213872 · 2022-07-15

ApplicantMorgan Scientific, Inc.
Decision Date2022-07-15
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ComPAS2 is a medical device manufactured by Morgan Scientific, Inc.. It received FDA 510(k) clearance on 2022-07-15 under approval number K213872. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ComPAS2?

ComPAS2 is a medical device that received FDA 510(k) clearance on 2022-07-15. It is manufactured by Morgan Scientific, Inc.. The 510(k) number is K213872.

When was ComPAS2 approved by the FDA?

ComPAS2 received FDA 510(k) clearance on 2022-07-15, under approval number K213872.

What company makes ComPAS2?

ComPAS2 is manufactured by Morgan Scientific, Inc..

What is the FDA product code for ComPAS2?

The FDA product code for ComPAS2 is BZG.

Other Devices by Morgan Scientific, Inc.

K190568ComPAS2 (Computerized Pulmonary Analysis System)

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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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