Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

OTC - Over The Counter
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back to Search Results
Document NumberK090766
Test Name Lifeloc Technologies, Inc. LifeGuard Breath Alcohol Tester  
Manufacturer NameLifeloc Technologies, Inc.
Consumer Information Phone Number(877)266-1008
Test TypeAlcohol, breath
Effective Date03/05/2010
Device Classification Name Devices, Breath Trapping, Alcohol
510(k) Number K090766
Device Name LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER
Applicant
Lifeloc Technologies, Inc.
12441 W. 49th Ave.
Suite 4
Wheat Ridge,  CO  80033
Applicant Contact MARK LARY
Correspondent
Lifeloc Technologies, Inc.
12441 W. 49th Ave.
Suite 4
Wheat Ridge,  CO  80033
Correspondent Contact MARK LARY
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received03/23/2009
Decision Date 07/23/2009
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 No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-