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Compumedics Siesta System

by Compumedics Limited

510(k) K003175

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003175 Date27 Dec 2000ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
OLV
Device class
Class II
Regulation
21 CFR Part 882.1400
Advisory committee
Neurology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Compumedics Siesta System is a standard polysomnograph with electroencephalograph. It is a multi-functional, ambulatory recording device that enables recording, monitoring, storage and transfer of up to 32 physiological data inputs, such as brain, heart and muscle activity.

The device is supplied for use in ambulatory settings, including hospital and home environments. It is designed for patient comfort and supports multiple days of recording on a reliable platform. The system has received FDA 510(k) clearance under k-number K003175 and is classified as a Class II medical device under regulation number 882.1400 with product code OLV.

Devices cleared under K003175

2 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K003175
UDI-DISize and differences
Siesta 802 Basic EEG System
COMPUMEDICS USA, INC.
9007-0061-01 / Siesta 802 Basic EEG System09342451002112 —On the market
Siesta 802 Basic PSG System
COMPUMEDICS USA, INC.
9007-0060-00 / Siesta 802 Basic PSG System09342451001788 —On the market

Similar devices

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

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