VitalScan ANS— 510(k) K191266

Substantially Equivalent

Medeia, Inc.

FDA 510(k) clearance K191266 for VitalScan ANS, Substantially Equivalent on 2020-01-15. Applicant: Medeia, Inc.. Device class: 2.

Clearance details

Applicant: Medeia, Inc.
Product code: Code JOM
Device class: Class 2
Regulation: 21 CFR 870.2780
Advisory panel: Cardiovascular
Date received: 2019-05-10
Decision date: 2020-01-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOM

K220527 — PADnet Xpress2022-10-20
K213730 — MESI mTABLET TBI diagnostic system, MESI mTABLET TBI2022-04-21
K200567 — ASI Plethysmogrpah Analyzer2021-02-26
K201046 — Automated ankle brachial pressure index measuring device, MESI mTABLET system2020-12-11
K172655 — Automated ankle brachial pressure index measuring device2018-01-11

More clearances from Medeia, Inc.

K212684 — BrainView QEEG Software2023-01-28
K192753 — NeuralScan System2020-03-17
K150804 — QBioScan2015-10-19

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