Sensormedics 4000 Series Sleep System
FDA 510(k) K915856 · Sensor Medics Corp.
510(k) numberK915856
Submission
- Device name
- Sensormedics 4000 Series Sleep System
- Applicant
- Sensor Medics Corp.
Yorba Linda, CA, US - Received
- December 27, 1991
- Decision date
- October 26, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OLZ – Automatic Event Detection Software For Polysomnograph With Electroencephalograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.1400
- Specialty
- Neurology
Automatically mark electroencephalograph and polysomongraph signals in order to aid in identification of such events and annotation of prolonged PSG traces; Automatically calculate simple measures obtained from recorded signals (e.G. Magnitude, time, frequency and simple statistical measures of marked events); All output subject to verification by qualified user
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|---|---|---|---|
| K253390 | Somnum (Somnum)OLZ · Traditional | Honeynaps Co., Ltd. | 06/27/2026SE |
| K253668 | Onera SleepMap (SLEEPMAP)OLZ · Traditional | Onera B.V. | 03/08/2026SE |
| K250851 | Hypnos (369054-200)OLZ · Traditional | Cadwell Industries, Inc. | 12/14/2025SE |
| K252330 | DeepRESPOLZ · Traditional | Nox Medical Ehf | 11/17/2025SE |
| K250058 | Neat 001OLZ · Traditional | Brain Electrophysiology Laboratory Company, LLC | 04/10/2025SE |
| K241960 | DeepRESPOLZ · Traditional | Nox Medical Ehf | 03/14/2025SE |
| K242094 | Dreem 3SOLZ · Traditional | Beacon Biosignals, Inc. | 11/22/2024SE |
| K233438 | SleepStageMLOLZ · Traditional | Beacon Biosignals, Inc. | 03/08/2024SE |
| K223539 | Dreem 3SOLZ · Traditional | Beacon Biosignals, Inc. | 08/18/2023SE |
| K223922 | Somnum (V.1.1.2.)OLZ · Traditional | Honeynaps Co., Ltd. | 08/16/2023SE |
More from Honeynaps Co., Ltd.
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| K032516 | HIOX80 Aerosol AdapterCAF · Traditional | 03/04/2004SE |
| K031745 | Infant Flow Plus Infant CPAP System with Sipap FunctionBZD · Traditional | 02/13/2004SE |
| K031883 | Lyra Nasal MaskBZD · Traditional | 08/25/2003SE |
| K030943 | Modification to HioxCBP · Traditional | 04/22/2003SE |
| K022192 | Pegasus Nasal CPAP SystemBZD · Traditional | 01/24/2003SE |
| K020665 | Hi-OxCBP · Traditional | 07/30/2002SE |
| K012085 | Somno Star & Series Sleep SystemOLV · Special | 08/02/2001SE |
| K012034 | Modification to: Sipap Infant Nasal CPAP CircuitBZD · Special | 07/24/2001SE |
| K991972 | Infant Flow SystemBZD · Special | 08/13/1999SE |
| K984254 | Infant Flow Ncpap MasksBZD · Traditional | 02/24/1999SE |
Questions and answers
When was Sensormedics 4000 Series Sleep System cleared by the FDA?
Sensormedics 4000 Series Sleep System (K915856) received a 510(k) decision of Substantially Equivalent on October 26, 1992, 304 days after the submission was received.
What is the product code of K915856?
The FDA product code is OLZ – Automatic Event Detection Software For Polysomnograph With Electroencephalograph, a Class II (moderate risk) device regulated under 21 CFR 882.1400.