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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
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