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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name calculator, pulmonary function data
510(k) Number K102047
Device Name LCI OPTION FOR INNOCOR
Applicant
INNOVISION A/S
10 E. SCRANTON AVE.,
SUITE 201
LAKE BLUFF,  IL  60044
Applicant Contact H. CARL JENKINS
Correspondent
INNOVISION A/S
10 E. SCRANTON AVE.,
SUITE 201
LAKE BLUFF,  IL  60044
Correspondent Contact H. CARL JENKINS
Regulation Number868.1880
Classification Product Code
BZC  
Date Received07/21/2010
Decision Date 11/01/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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