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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 St., P.O. Box 389
Tirat Hacarmel,  IL 39554
Applicant Contact CHARLES S IRVING
Correspondent
Karmel Medical Acoustic Technologies , Ltd.
9 Ezel St., P.O. 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
Predetermined Change
Control Plan Authorized		 No
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