PSG-1100 SLEEP DIAGNOSTIC SYSTEM— 510(k) K120888

Name: FDA 510(k) clearance K120888
Creator: U.S. Food and Drug Administration
Published: 2012-11-09

Substantially Equivalent

Nihon Kohden Corp.

FDA 510(k) clearance K120888 for PSG-1100 SLEEP DIAGNOSTIC SYSTEM, Substantially Equivalent on 2012-11-09. Applicant: Nihon Kohden Corp.. Device class: 2.

Clearance details

Applicant: Nihon Kohden Corp.
Product code: Code GWQ
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2012-03-23
Decision date: 2012-11-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Foothill, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K120888

K-number listed on FDA's recall record

Z-0865-2021 — PSG-1100 Sleep Diagnostic System. Sample product label: JB-110A SERIAL No. 01454 RoHS Compliant; PSG-100 Head Box; UDI (01) 04931921108383; Made in Japan The PSG-1100 Sleep Diagnostic System is a digital PSG amplifier intended to record the electrical activity of the brain (EEG) and other bio-potential signals and to record physiological data required for sleep studies.Class II·Ongoing·Nihon Kohden America Inc·20201221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120888.

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