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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 K120880
Device Name ORBIT
Applicant
National Biomedical, LLC Dba Qrs Diagnostic
6901 E. Fish Lake Rd., Suite 188
Maple Grove,  MN  55369
Applicant Contact MARY KAY JENSEN
Correspondent
National Biomedical, LLC Dba Qrs Diagnostic
6901 E. Fish Lake Rd., Suite 188
Maple Grove,  MN  55369
Correspondent Contact MARY KAY JENSEN
Regulation Number868.1840
Classification Product Code
BZG  
Date Received03/23/2012
Decision Date 04/19/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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