microTargeting Guideline 4000 5.0 System— 510(k) K183123

Name: FDA 510(k) clearance K183123
Creator: U.S. Food and Drug Administration
Published: 2018-12-20

Substantially Equivalent

FHC, Inc.

FDA 510(k) clearance K183123 for microTargeting Guideline 4000 5.0 System, Substantially Equivalent on 2018-12-20. Applicant: FHC, Inc.. Device class: 2.

Clearance details

Applicant: FHC, Inc.
Product code: Code GZL
Device class: Class 2
Regulation: 21 CFR 882.1330
Advisory panel: Neurology
Date received: 2018-11-13
Decision date: 2018-12-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Bowdoin, ME, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K183123

K-number listed on FDA's recall record

Z-2540-2020 — FHC Guideline 4000 5.0 GL5 Main Processing Unit - Product Usage: intended to record and stimulate electrophysiological activity, as well as aid in the accurate placement of electrodes and other instruments. Catalogue Number: C0215 UDI: 00873263006740Class II·Terminated·FHC, Inc.·20200617

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K183123.

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