Video EEG Option Modification

FDA 510(k) K933951 · Esaote Biomedica Spa

Substantially Equivalent

510(k) numberK933951

Submission

Device name
Video EEG Option Modification
Applicant
Esaote Biomedica Spa
Indianapolis, IN, US
Received
August 12, 1993
Decision date
February 3, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GWQ – Full-Montage Standard Electroencephalograph
Device class
Class II (moderate risk)
Regulation
21 CFR 882.1400
Specialty
Neurology

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

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Questions and answers

When was Video EEG Option Modification cleared by the FDA?

Video EEG Option Modification (K933951) received a 510(k) decision of Substantially Equivalent on February 3, 1994, 175 days after the submission was received.

What is the product code of K933951?

The FDA product code is GWQ – Full-Montage Standard Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.