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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spirometer, diagnostic
510(k) Number K093174
Device Name SPIROPALM
Applicant
COSMED S.R.L.
1129 BLOOMFIELD AVENUE
SUITE 202
WEST CALDWELL,  NJ  07006
Applicant Contact ROBERT SCHIFF
Correspondent
COSMED S.R.L.
1129 BLOOMFIELD AVENUE
SUITE 202
WEST CALDWELL,  NJ  07006
Correspondent Contact ROBERT SCHIFF
Regulation Number868.1840
Classification Product Code
BZG  
Date Received10/08/2009
Decision Date 02/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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