Cerebral State Monitor - CSM

FDA 510(k) K042315 · Danmeter A/S

Substantially Equivalent

510(k) numberK042315

Submission

Device name
Cerebral State Monitor - CSM
Applicant
Danmeter A/S
Odense C, DK
Received
August 26, 2004
Decision date
January 21, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OLW – Index-Generating Electroencephalograph Software
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Specialty
Neurology

Analyze electrical activity of the brain by transformation of electroencephalograph signals into a dimensionless index number for use and interpretation by a qualified user.

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Questions and answers

When was Cerebral State Monitor - CSM cleared by the FDA?

Cerebral State Monitor - CSM (K042315) received a 510(k) decision of Substantially Equivalent on January 21, 2005, 148 days after the submission was received.

What is the product code of K042315?

The FDA product code is OLW – Index-Generating Electroencephalograph Software, a Class II (moderate risk) device regulated under 21 CFR 882.1400.