FDA 510(k)

ComPAS2

K-Number: K213872 · 2022-07-15

Decision Date2022-07-15

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

ComPAS2 is the device name listed in this FDA 510(k) record. The listed applicant is Morgan Scientific, Inc.. It received FDA 510(k) clearance on 2022-07-15 under 510(k) 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. The listed applicant is Morgan Scientific, Inc.. The 510(k) number is K213872.

When did ComPAS2 receive FDA 510(k) clearance?

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

Who is the listed applicant for ComPAS2?

The FDA 510(k) record lists Morgan Scientific, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ComPAS2?

The FDA product code for ComPAS2 is BZG.

Other records listing Morgan Scientific, Inc. 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.

K190568ComPAS2 (Computerized Pulmonary Analysis System)

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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.