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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name device, positive pressure breathing, intermittent
510(k) Number K140598
Device Name PEGASO COUGH, PEGASO A-COUGH, PEGASO A-COUGH PERC
Applicant
DIMA ITALIA SRL
via Coriolano Vighi, 29
Bologna,  IT 40133
Applicant Contact DARIO BASCIU
Correspondent
DIMA ITALIA SRL
via Coriolano Vighi, 29
Bologna,  IT 40133
Correspondent Contact DARIO BASCIU
Regulation Number868.5905
Classification Product Code
NHJ  
Date Received03/10/2014
Decision Date 10/16/2014
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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