REDLINE ALCOHOL BREATH TESTER


Device Classification Name

devices, breath trapping, alcohol

510(k) Number K072953
Device Name REDLINE ALCOHOL BREATH TESTER
Applicant
REDLINE PRODUCTS (PTY) LTD.
10 crompton road
strand industria, western cape, 

ZA

7140

Applicant Contact hugh a butler
Correspondent
REDLINE PRODUCTS (PTY) LTD.
10 crompton road
strand industria, western cape, 

ZA

7140

Correspodent Contact hugh a butler
Regulation Number 862.3050
Classification Product Code
DJZ  
Date Received 10/18/2007
Decision Date 01/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No