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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 K213872
Device Name ComPAS2
Applicant
Morgan Scientific, Inc.
151 Essex St. Suite 8
Haverhill,  MA  01832
Applicant Contact Deborah Cornish
Correspondent
Morgan Scientific, Inc.
151 Essex St. Suite 8
Haverhill,  MA  01832
Correspondent Contact Deborah Cornish
Regulation Number868.1840
Classification Product Code
BZG  
Date Received12/13/2021
Decision Date 07/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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