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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 K020280
Device Name PULMOLAB EX671 EXERCISE TESTING SYSTEM
Applicant
Morgan Medical , Ltd.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Applicant Contact JONATHAN S KAHAN
Correspondent
Morgan Medical , Ltd.
555 Thirteenth St., NW
Washington,  DC  20004 -1109
Correspondent Contact JONATHAN S KAHAN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received01/28/2002
Decision Date 09/24/2002
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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