Cleared Traditional

K020335 - OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330
(FDA 510(k) Clearance)

K020335 · Olympic Medical Corp. · Neurology

Jun 2002

Decision

137d

Days

Class 2

Risk

K020335 is an FDA 510(k) clearance for the OLYMPIC MEDICAL LECTROMED CEREBRAL FUNCTION MONITOR SYSTEM, MODEL 5330, a Reduced- Montage Standard Electroencephalograph (Class II — Special Controls, product code OMC), submitted by Olympic Medical Corp. (Seattle, US). The FDA issued a Cleared decision on June 18, 2002, 137 days after receiving the submission on February 1, 2002. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K020335 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2002
Decision Date	June 18, 2002
Days to Decision	137 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	OMC — Reduced- Montage Standard Electroencephalograph
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 882.1400
Definition	Acquire, Display, Store, And Archive Electroencephalographic Signals From The Brain Using A User-specified And/or Sponsor-specified Locations With A Reduced Array (i.e. Less Than < 16) Of Electrodes