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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 K021200
Device Name COMPAS
Applicant
MORGAN SCIENTIFIC, INC.
151 ESSEX ST.
HAVERHILL,  MA  01832
Applicant Contact PATRICK F MORGAN
Correspondent
MORGAN SCIENTIFIC, INC.
151 ESSEX ST.
HAVERHILL,  MA  01832
Correspondent Contact PATRICK F MORGAN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received04/16/2002
Decision Date 10/18/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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