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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plethysmograph, Volume
510(k) Number K022636
Device Name BODY BOX 5500
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 Number868.1760
Classification Product Code
JEH  
Date Received08/08/2002
Decision Date 01/13/2003
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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