Siesta 802 Basic EEG System

• FDA 510(k) K003175 decided 27 Dec 2000 Active
• FDA GUDID UDI-DI 09342451002112 listed 16 Dec 2020 Listed

1. 27 Dec 2000 Cleared FDA 510(k) K003175
2. 16 Dec 2020 Listed FDA GUDID 09342451002112

Trade name

Siesta

Generic name

Electroencephalographic ambulatory recorder

Model / Ref / Catalog

Siesta 802 Basic EEG System, 9007-0061-01

Primary DI / UDI-DI

09342451002112

510(k) Number

K003175 ↗

FDA product code

OLV, GWQ

GMDN term

Electroencephalographic ambulatory recorder

Device class

Class II

Regulation number

882.1400

GUDID distribution status

In Commercial Distribution

Category: Electroencephalographic ambulatory recorder

Other devices filed under FDA product code OLV (Standard Polysomnograph With Electroencephalograph).

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• Micromed SD LTM 64 PLUS by Micromed, Inc.
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