Who is the manufacturer of ACTIWARE-PLMS?

Mini-Mitter Co., Inc. submitted the Special clearance for ACTIWARE-PLMS (K011430).

What is the FDA product code for ACTIWARE-PLMS?

GWQ. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for ACTIWARE-PLMS?

510(k) clearance (submission type: Special).

ACTIWARE-PLMS

K011430 · Mini-Mitter Co., Inc. · GWQ · May 31, 2001 · Neurology

Device Facts

Record ID	K011430
Device Name	ACTIWARE-PLMS
Applicant	Mini-Mitter Co., Inc.
Product Code	GWQ · Neurology
Decision Date	May 31, 2001
Decision	SESE
Submission Type	Special
Regulation	21 CFR 882.1400
Device Class	Class 2

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.