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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator, Predicted Values, Pulmonary Function
510(k) Number K040549
Device Name COSMED PONY FX
Applicant
COSMED S.R.L.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
COSMED S.R.L.
1129 BLOOMFIELD AVE.
WEST CALDWELL,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number868.1890
Classification Product Code
BTY  
Subsequent Product Code
DQA  
Date Received03/02/2004
Decision Date 09/28/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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