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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, pulmonary function interpretor (diagnostic)
510(k) Number K980878
Device Name PULMOTRACK,MODEL 1010
Applicant
KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD.
9 EZEL STREET, PO BOX 389
TIRAT HACARMEL,  IL 39554
Applicant Contact CHARLES S IRVING
Correspondent
KARMEL MEDICAL ACOUSTIC TECHNOLOGIES LTD.
9 EZEL STREET, PO BOX 389
TIRAT HACARMEL,  IL 39554
Correspondent Contact CHARLES S IRVING
Regulation Number868.1900
Classification Product Code
BZM  
Date Received03/09/1998
Decision Date 12/28/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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