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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 data
510(k) Number K801920
Device Name SYSTEM 80 COMPUTERIZED SPIROMETER
Applicant
PULMONARY TESTING SYSTEMS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
PULMONARY TESTING SYSTEMS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1880
Classification Product Code
BZC  
Date Received08/11/1980
Decision Date 10/03/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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