510(k) K891383

MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM by Oxford Medilog, Inc. — Product Code OLZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 1, 1989
Date Received: March 9, 1989
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Automatic Event Detection Software For Polysomnograph With Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

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 clearances by Oxford Medilog, Inc.

K923737 — MODEL MEDILOG RAPIDE (January 5, 1994)
K920295 — MEDILOG EXCEL ECG ANALYSIS SYSTEM (MODIFIED) (August 18, 1992)
K912890 — MODEL SONICAID AXIS (January 9, 1992)
K912639 — SONICAID TEAM (December 31, 1991)
K904763 — MENTOR EEG SYSTEM (April 10, 1991)
K902690 — SONICAID MODEL MERIDIAN 800 (February 5, 1991)
K895909 — SONICAID MODEL VASOFLO 4 (July 9, 1990)
K896535 — MEDILOG OPTIMA (January 18, 1990)
K890330 — MEDILOG 6000-FD REPORT GENERATOR (April 20, 1989)
K890338 — MEDILOG EDITOR (April 19, 1989)

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K233438 — SleepStageML (March 8, 2024)
K223539 — Dreem 3S (August 18, 2023)
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