ComPAS2 (Computerized Pulmonary Analysis System)— 510(k) K190568

Name: FDA 510(k) clearance K190568
Creator: U.S. Food and Drug Administration
Published: 2019-06-06

Substantially Equivalent

Morgan Scientific, Inc.

FDA 510(k) clearance K190568 for ComPAS2 (Computerized Pulmonary Analysis System), Substantially Equivalent on 2019-06-06. Applicant: Morgan Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Morgan Scientific, Inc.
Product code: Code BZG
Device class: Class 2
Regulation: 21 CFR 868.1840
Advisory panel: Anesthesiology
Date received: 2019-03-06
Decision date: 2019-06-06
Decision: Substantially Equivalent
Clearance type: Special
Location: Haverhill, MA, US

Download summary PDF View on FDA.gov ↗

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