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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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