Compumedics Siesta System
FDA 510(k) K003175 · Compumedics Limited
510(k) numberK003175
Submission
- Device name
- Compumedics Siesta System
- Applicant
- Compumedics Limited
Minneapolis,, MN, US - Received
- October 10, 2000
- Decision date
- December 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLV – Standard Polysomnograph With Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Acquire, display, store, and archive electroencephalographic signals from the brain and other signals (such as electromyography, respiratory and/or oximetry signals) for sleep recordings. May also be used to allow on-screen review, user-controlled annotation and user-controlled marking of data.
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More from Neurotronics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252383 | Somfit DMNR · Special | 08/28/2025SE |
| K242447 | Falcon HSTOLV · Traditional | 02/20/2025SE |
| K231546 | SomfitMNR · Traditional | 11/30/2023SE |
| K230073 | OktiGWQ · Traditional | 02/09/2023SE |
| K191785 | Orion LifeSpan MEGOLY · Traditional | 02/14/2020SE |
| K093223 | Compumedics Grael System, Models: Grael, Grael ECGGWQ · Traditional | 01/15/2010SE |
| K072201 | Compumedics Somte PSG Recording SystemMNR · Traditional | 04/14/2008SE |
| K021176 | Compumedics Somte SystemMNR · Traditional | 01/21/2003SE |
Questions and answers
When was Compumedics Siesta System cleared by the FDA?
Compumedics Siesta System (K003175) received a 510(k) decision of Substantially Equivalent on December 27, 2000, 78 days after the submission was received.
What is the product code of K003175?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.