AITRICS-VC— 510(k) K240756

Substantially Equivalent

Aitrics Co., Ltd.

FDA 510(k) clearance K240756 for AITRICS-VC, Substantially Equivalent on 2024-07-23. Applicant: Aitrics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Aitrics Co., Ltd.
Product code: Code PLB
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2024-03-20
Decision date: 2024-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

Recent devices under product code PLB

K240558 — NAVOYCDS2024-07-22
K230386 — SpassageQ2023-06-15
K213423 — T3 Platform software2023-01-06
K183282 — Biovitals Analytics Engine2019-08-15
K152258 — T3 Software2016-03-31

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