Cervella— 510(k) K182311

Substantially Equivalent

Innovative Neurological Devices, LLC

FDA 510(k) clearance K182311 for Cervella, Substantially Equivalent on 2019-03-07. Applicant: Innovative Neurological Devices, LLC. Device class: 2.

Clearance details

Applicant: Innovative Neurological Devices, LLC
Product code: Code QJQ
Device class: Class 2
Regulation: 21 CFR 882.5800
Advisory panel: Neurology
Date received: 2018-08-24
Decision date: 2019-03-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carmel, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QJQ

K252951 — Genesis Sleep2025-12-31
K232253 — Modius Stress2024-03-27
K230826 — Modius Sleep2023-10-27
K090052 — CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C2009-05-29
K070412 — ELEXOMA MEDIC2008-05-21

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