BreathID® Smart System— 510(k) K223185

Name: FDA 510(k) clearance K223185
Creator: U.S. Food and Drug Administration
Published: 2022-11-10

Substantially Equivalent

Meridian Bioscience Israel , Ltd.

FDA 510(k) clearance K223185 for BreathID® Smart System, Substantially Equivalent on 2022-11-10. Applicant: Meridian Bioscience Israel , Ltd.. Device class: 1.

Clearance details

Applicant: Meridian Bioscience Israel , Ltd.
Product code: Code MSQ
Device class: Class 1
Regulation: 21 CFR 866.3110
Advisory panel: Microbiology
Date received: 2022-10-12
Decision date: 2022-11-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Modiin, IL

Download summary PDF View on FDA.gov ↗

Recent devices under product code MSQ

view all

K221896 — BreathID Hp System2022-12-19
K220494 — BreathID Hp Lab System, BreathID Smart System2022-06-23
K193610 — BreathID Smart System2020-02-06
K173772 — BreathID Hp System2018-03-08
K173777 — BreathID Hp Lab System2018-03-08

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