Soberlink Cellular Device and Sober Sky Web Portal— 510(k) K160613

Name: FDA 510(k) clearance K160613
Creator: U.S. Food and Drug Administration
Published: 2016-07-14

Substantially Equivalent

Soberlink Healthcare, LLC

FDA 510(k) clearance K160613 for Soberlink Cellular Device and Sober Sky Web Portal, Substantially Equivalent on 2016-07-14. Applicant: Soberlink Healthcare, LLC. Device class: 1.

Clearance details

Applicant: Soberlink Healthcare, LLC
Product code: Code DJZ
Device class: Class 1
Regulation: 21 CFR 862.3050
Advisory panel: Clinical Toxicology
Date received: 2016-03-03
Decision date: 2016-07-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntington Beach, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DJZ

view all

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
K100879 — CONTRALCO2010-08-04

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