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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name spirometer, diagnostic
510(k) Number K190568
Device Name ComPAS2 (Computerized Pulmonary Analysis System)
Applicant
Morgan Scientific, Inc.
151 Essex Street STE 8
haverhill,  MA  01832
Applicant Contact deborah cornish
Correspondent
Morgan Scientific, Inc.
151 Essex Street STE 8
haverhill,  MA  01832
Correspondent Contact deborah cornish
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/06/2019
Decision Date 06/06/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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