Model 9160 VitaloQUB— 510(k) K223818

Substantially Equivalent

Vitalograph Ireland, Ltd.

FDA 510(k) clearance K223818 for Model 9160 VitaloQUB, Substantially Equivalent on 2023-05-25. Applicant: Vitalograph Ireland, Ltd.. Device class: 2.

Clearance details

Applicant: Vitalograph Ireland, Ltd.
Product code: Code JEH
Device class: Class 2
Regulation: 21 CFR 868.1760
Advisory panel: Anesthesiology
Date received: 2022-12-21
Decision date: 2023-05-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ennis Co Clare, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code JEH

K240706 — PowerCube+ Series (3 models)2024-12-09
K072061 — MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY2008-04-22
K022636 — BODY BOX 55002003-01-13
K960840 — C.E. VASCULAR MACHINE1997-03-28
K953642 — AP-181995-12-12

More clearances from Vitalograph Ireland, Ltd.

K221030 — Model 9100 PFT/DICO2022-07-15
K212938 — Vitalograph Model 6000 Alpha2022-01-26
K201562 — Spirotrac2020-10-14
K200550 — Vitalograph Model 2120 In2itive eDiary2020-07-27
K160253 — Vitalograph Model 6300 micro2016-08-26

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