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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 K810196
Device Name SYSTEM 84 COMPUTERIZED LUNG VOL. SPIROM
Applicant
CARDIO PULMONARY INSTRUMENTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
CARDIO PULMONARY INSTRUMENTS
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.1880
Classification Product Code
BZC  
Date Received01/23/1981
Decision Date 02/05/1981
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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