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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 K083879
Device Name INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500)
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 Number868.1840
Classification Product Code
BZG  
Date Received12/29/2008
Decision Date 02/23/2009
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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