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Siesta 802 Basic PSG System

by Compumedics USA, Inc.

Siesta 802 Basic PSG System (9007-0060-00) is a Class II device made by Compumedics USA, Inc., cleared under FDA 510(k) K003175 on 27 Dec 2000 and listed in FDA GUDID since 15 Dec 2020 (UDI-DI 09342451001788), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K003175

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number09342451001788 UDI-DI Date15 Dec 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK003175 Date27 Dec 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K003175 decided 27 Dec 2000 Active
  • FDA GUDID UDI-DI 09342451001788 listed 15 Dec 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K003175
  2. Listed FDA GUDID 09342451001788

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Siesta
Generic name
Polysomnograph
Model / Ref / Catalog
Siesta 802 Basic PSG System, 9007-0060-00
Primary DI / UDI-DI
09342451001788
510(k) Number
FDA product code
OLV, GWQ
GMDN term
Polysomnograph
Device class
Class II
Regulation number
882.1400
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polysomnograph

Cleared under the same submission (K003175)

Similar devices in this category

Other devices filed under Polysomnograph.

Other devices from Compumedics USA, Inc.

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)