Xltek Sleep System
FDA 510(k) K022037 · Excel Tech. , Ltd.
510(k) numberK022037
Submission
- Device name
- Xltek Sleep System
- Applicant
- Excel Tech. , Ltd.
Oakville, CA - Received
- June 24, 2002
- Decision date
- September 10, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K062549 | Xltek Stimulator Probes, Models 105233, 105234, 105235, 105236, 105237 and 105238ETN · Traditional | 10/04/2006SE |
| K061269 | Xltek Clean Signal Adhesive ElectrodesGXY · Traditional | 08/14/2006SE |
| K053386 | Xltek EMU40 EEG Headbox, Model PK1072GWQ · Traditional | 04/21/2006SE |
| K053058 | Xltek Neuropath, Model PK1070JXE · Traditional | 02/07/2006SE |
| K052112 | Xltek Xcalibur Emg / LT, Model PK1P33, PK1059IKN · Special | 10/28/2005SE |
| K052111 | Xltek Clear Signal Sub-Dermal Needle, Models 102889, 102798, 102799, 102382GXZ · Abbreviated | 08/17/2005SE |
| K042223 | Xltek Connex Ip Headbox, Model 1054OMB · Special | 09/16/2004SE |
| K042150 | Xltek Trex MODEL#10309GWQ · Special | 08/27/2004SE |
| K040358 | Xltek Protektor Stimulator, Models 10247 & 10248GWF · Traditional | 08/06/2004SE |
| K040360 | EMU128S, Model EX-NW-128SGWQ · Special | 03/12/2004SE |
Questions and answers
When was Xltek Sleep System cleared by the FDA?
Xltek Sleep System (K022037) received a 510(k) decision of Substantially Equivalent on September 10, 2002, 78 days after the submission was received.
What is the product code of K022037?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.