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FDA 510(k)

ComPAS2 (Computerized Pulmonary Analysis System)

K-Number: K190568 · 2019-06-06

ApplicantMorgan Scientific, Inc.
Decision Date2019-06-06
Product CodeBZG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ComPAS2 (Computerized Pulmonary Analysis System) is a medical device manufactured by Morgan Scientific, Inc.. It received FDA 510(k) clearance on 2019-06-06 under approval number K190568. 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 (Computerized Pulmonary Analysis System)?

ComPAS2 (Computerized Pulmonary Analysis System) is a medical device that received FDA 510(k) clearance on 2019-06-06. It is manufactured by Morgan Scientific, Inc.. The 510(k) number is K190568.

When was ComPAS2 (Computerized Pulmonary Analysis System) approved by the FDA?

ComPAS2 (Computerized Pulmonary Analysis System) received FDA 510(k) clearance on 2019-06-06, under approval number K190568.

What company makes ComPAS2 (Computerized Pulmonary Analysis System)?

ComPAS2 (Computerized Pulmonary Analysis System) is manufactured by Morgan Scientific, Inc..

What is the FDA product code for ComPAS2 (Computerized Pulmonary Analysis System)?

The FDA product code for ComPAS2 (Computerized Pulmonary Analysis System) is BZG.

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Related PubMed Literature

PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41712188 A Simulation-Based Root Cause Analysis of Pediatric Medication Dosing Errors in Emergency Medical Services. Prehospital emergency care (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Other Devices by Morgan Scientific, Inc.

K213872ComPAS2

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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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