LCI OPTION FOR INNOCOR— 510(k) K102047

Substantially Equivalent

Innovision A/S

FDA 510(k) clearance K102047 for LCI OPTION FOR INNOCOR, Substantially Equivalent on 2011-11-01. Applicant: Innovision A/S. Device class: 2.

Clearance details

Applicant: Innovision A/S
Product code: Code BZC
Device class: Class 2
Regulation: 21 CFR 868.1880
Advisory panel: Anesthesiology
Date received: 2010-07-21
Decision date: 2011-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Bluff, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZC

K240293 — STS2024-09-17
K183567 — Vyntus/SentrySuite Product Line2019-08-23
K190853 — Vyntus BODY2019-08-16
K181524 — Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART2018-11-30
K162515 — COSMED K5 Wearable Metabolic Technology2017-06-20

More clearances from Innovision A/S

Recalls naming K102047

K-number listed on FDA's recall record

Z-2769-2016 — Innocor Cardiopulmonary Exercise and Lung Function Testing System Non-invasive diagnostic device that measures or calculates a number of hemodynamic and metabolic parameters.Class II·Terminated·Innovision A/S·20160513

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K102047.

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