Xltek Polysomnography Headbox, Model # PSG-40
FDA 510(k) K991900 · Excel Tech. , Ltd.
510(k) numberK991900
Submission
- Device name
- Xltek Polysomnography Headbox, Model # PSG-40
- Applicant
- Excel Tech. , Ltd.
Oakville,Ontario, CA - Received
- June 4, 1999
- Decision date
- July 12, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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.
Other 510(k)s with product code OLV
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261747 | Report StudioOLV · Traditional | Beacon Biosignals, Inc. | 08/25/2026SE |
| K260585 | Noxturnal WebOLV · Special | Nox Medical Ehf | 03/20/2026SE |
| K242447 | Falcon HSTOLV · Traditional | Compumedics Limited | 02/20/2025SE |
| K241288 | Noxturnal WebOLV · Traditional | Nox Medical Ehf | 12/23/2024SE |
| K240700 | HomeSleepTest (HST, HST REM+)OLV · Traditional | Somnomedics GmbH | 12/08/2024SE |
| K213007 | Cerebra Sleep SystemOLV · Traditional | Cerebra Medical , Ltd. | 07/06/2022SE |
| K201054 | SOMNOscreen plusOLV · Traditional | Somnomedics GmbH | 08/12/2020SE |
| K192624 | ApneaTrakOLV · Traditional | Cadwell Industries, Inc. | 02/20/2020SE |
| K181709 | Serenity Piezo Sensor, Serenity Thermocouple SensorOLV · Traditional | Neurotronics, Inc. | 11/16/2018SE |
| K173868 | Serenity Body Position Sensor, Serenity RIP SensorsOLV · Traditional | Neurotronics, Inc. | 07/02/2018SE |
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 Polysomnography Headbox, Model # PSG-40 cleared by the FDA?
Xltek Polysomnography Headbox, Model # PSG-40 (K991900) received a 510(k) decision of Substantially Equivalent on July 12, 1999, 38 days after the submission was received.
What is the product code of K991900?
The FDA product code is OLV – Standard Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.