Medilog 9200 EEG Replay/Analysis System
FDA 510(k) K891383 · Oxford Medilog, Inc.
510(k) numberK891383
Submission
- Device name
- Medilog 9200 EEG Replay/Analysis System
- Applicant
- Oxford Medilog, Inc.
Clearwater, FL, US - Received
- March 9, 1989
- Decision date
- June 1, 1989
- 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
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| 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 |
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| K923737 | Model Medilog RapideBZQ · Traditional | 01/05/1994SE |
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| K912890 | Model Sonicaid AxisHGM · Traditional | 01/09/1992SE |
| K912639 | Sonicaid TeamHGM · Traditional | 12/31/1991SE |
| K904763 | Mentor EEG SystemGWQ · Traditional | 04/10/1991SE |
| K902690 | Sonicaid Model Meridian 800HGM · Traditional | 02/05/1991SE |
| K895909 | Sonicaid Model Vasoflo 4MAA · Traditional | 07/09/1990SE |
| K896535 | Medilog OptimaDSK · Traditional | 01/18/1990SE |
| K890330 | Medilog 6000-FD Report GeneratorDSI · Traditional | 04/20/1989SE |
| K890338 | Medilog EditorDSI · Traditional | 04/19/1989SE |
Questions and answers
When was Medilog 9200 EEG Replay/Analysis System cleared by the FDA?
Medilog 9200 EEG Replay/Analysis System (K891383) received a 510(k) decision of Substantially Equivalent on June 1, 1989, 84 days after the submission was received.
What is the product code of K891383?
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.