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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 K963373
Device Name COSMED K4
Applicant
COSMED S.R.L.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Applicant Contact ANNE MARIE CESARIO
Correspondent
COSMED S.R.L.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Correspondent Contact ANNE MARIE CESARIO
Regulation Number868.1880
Classification Product Code
BZC  
Date Received08/27/1996
Decision Date 09/10/1997
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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