COMPONENT NEUROMONITORING SYSTEM— 510(k) K080217

Name: FDA 510(k) clearance K080217
Creator: U.S. Food and Drug Administration
Published: 2008-11-05

Substantially Equivalent

Moberg Research, Inc.

FDA 510(k) clearance K080217 for COMPONENT NEUROMONITORING SYSTEM, Substantially Equivalent on 2008-11-05. Applicant: Moberg Research, Inc.. Device class: 2.

Clearance details

Applicant: Moberg Research, Inc.
Product code: Code OMA
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2008-01-29
Decision date: 2008-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ambler, PA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K080217

K-number listed on FDA's recall record

Z-1338-2023 — Moberg Component Neuromonitoring System (CNS Monitor)-Intended as a short-term neurological monitoring system that collects, displays, and stores multiple physiological measurements Model: CNS-350Class II·Ongoing·Moberg Research, Inc.·20230220

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080217.

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