LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER— 510(k) K090766

Name: FDA 510(k) clearance K090766
Creator: U.S. Food and Drug Administration
Published: 2009-07-23

Substantially Equivalent

Lifeloc Technologies, Inc.

FDA 510(k) clearance K090766 for LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER, Substantially Equivalent on 2009-07-23. Applicant: Lifeloc Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Lifeloc Technologies, Inc.
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2009-03-23
Decision date: 2009-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DJZ

view all

K160613 — Soberlink Cellular Device and Sober Sky Web Portal2016-07-14
K123470 — PAS ALCOVISOR MARS, PAS ALCOVISOR SATELLITE2013-04-29
K110614 — PAD (PERSONAL ALCOHOL DETECTOR) BREATH ALCOHOL TEST SYSTEM2011-11-21
K102225 — ALCO-BREATH TUBE, CHECKPOINT BREATH ALCOHOL TEST2011-04-06
K102338 — BREATHSCN PRO2011-01-12

Data sourced from openFDA. This site is unofficial and independent of the FDA.