Sleep Analyzing Computer
FDA 510(k) K862527 · Micro Tronics Corp.
510(k) numberK862527
Submission
- Device name
- Sleep Analyzing Computer
- Applicant
- Micro Tronics Corp.
Carrboro, NC, US - Received
- July 2, 1986
- Decision date
- October 6, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code OLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K901797 | The Wonder BoxGWL · Traditional | 02/07/1991SE |
| K890513 | Sac 747 and Sac 847 (Sleep Analyzing Computers)OLZ · Traditional | 04/28/1989SE |
| K863124 | Model 8 EEG PreamplifierGWQ · Traditional | 11/18/1986SE |
| K780838 | PerciBXX · Traditional | 07/17/1978SE |
| K772005 | Myotone Emg MonitorIKN · Traditional | 11/23/1977SE |
Questions and answers
When was Sleep Analyzing Computer cleared by the FDA?
Sleep Analyzing Computer (K862527) received a 510(k) decision of Substantially Equivalent on October 6, 1986, 96 days after the submission was received.
What is the product code of K862527?
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.