Cleared Traditional

COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG

K093223 · Compumedics Limited · Neurology

Jan 2010

Decision

94d

Days

Class 2

Risk

About This 510(k) Submission

K093223 is an FDA 510(k) clearance for the COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG, a Full-montage Standard Electroencephalograph (Class II — Special Controls, product code GWQ), submitted by Compumedics Limited (Abbotsford, Victoria, AU). The FDA issued a Cleared decision on January 15, 2010, 94 days after receiving the submission on October 13, 2009. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1400.

Submission Details

510(k) Number	K093223 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 13, 2009
Decision Date	January 15, 2010
Days to Decision	94 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF

Device Classification

Product Code	GWQ — Full-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 Full Montage Array (i.e., 16 Or More Electrodes) And User-specified Locations