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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilatory effort recorder
510(k) Number K061996
FOIA Releasable 510(k) K061996
Device Name SANDMAN POCKET
Applicant
EB NEURO, S.P.A.
11460 N. MERIDIAN ST.
SUITE 150
CARMEL,  IN  46032
Applicant Contact CARRI GRAHAM
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number868.2375
Classification Product Code
MNR  
Date Received07/14/2006
Decision Date 10/03/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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