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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 K110486
Device Name ACCUSOM
Applicant
NOVASOM, INC.
801 CROMWELL PARK DRIVE
GLEN BURNIE,  MD  21061
Applicant Contact ROGER K RICHARDSON
Correspondent
NOVASOM, INC.
801 CROMWELL PARK DRIVE
GLEN BURNIE,  MD  21061
Correspondent Contact ROGER K RICHARDSON
Regulation Number868.2375
Classification Product Code
MNR  
Date Received02/22/2011
Decision Date 08/12/2011
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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