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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 K013752
Device Name COMPAS AS (COMPUTERIZED PULMONARY ANALYSIS SYSTEM)
Applicant
Morgan Scientific, Inc.
151 Essex St.
Haverhill,  MA  01832
Applicant Contact PATRICK MORGAN
Correspondent
Morgan Scientific, Inc.
151 Essex St.
Haverhill,  MA  01832
Correspondent Contact PATRICK MORGAN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received11/13/2001
Decision Date 01/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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