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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices, Breath Trapping, Alcohol
510(k) Number K052804
Device Name BREATHKEY MODEL G10/BREATHKEY MODEL G30X
Applicant
Omega Point Systems, LLC
310 Ter. Ave.
Suite 201
Cincinnati,  OH  45220
Applicant Contact BARBARA S FANT
Correspondent
Tuv America, Inc.
1775 Old Hwy. 8
New Brighton,  MN  55112
Correspondent Contact LAURA DANIELSON
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received10/04/2005
Decision Date 12/09/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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