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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 K993921
Device Name NDD MEDICAL TECHNOLOGIES EASYONE SPIROMETER: FRONTLINE MODEL 2000 AND DIAGNOSTIC MODEL 2001
Applicant
NDD MEDICAL TECHNOLOGIES
17 PROGRESS ANENUE
CHELMSFORD,  MA  01824
Applicant Contact OSCAR KAELIN
Correspondent
NDD MEDICAL TECHNOLOGIES
17 PROGRESS ANENUE
CHELMSFORD,  MA  01824
Correspondent Contact OSCAR KAELIN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received11/18/1999
Decision Date 05/23/2000
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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