510(k) K871500

MODEL 5000 AMBULATORY MONITORING SYSTEM by Oxford Medilog, Inc. — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: July 1, 1987
Date Received: April 16, 1987
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Full-Montage Standard Electroencephalograph
Device Class: Class II
Regulation Number: 882.1400
Review Panel: NE
Submission Type

Acquire, display, store, and archive electroencephalographic signals from the brain using a full montage array (i.e., 16 or more electrodes) and user-specified locations

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)
K891383 — MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM (June 1, 1989)
K890330 — MEDILOG 6000-FD REPORT GENERATOR (April 20, 1989)

Other clearances for product code GWQ

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K231366 — Neuronaute Plus (November 9, 2023)
K221959 — Q21 (August 31, 2023)
K231457 — SPARK Scan (August 18, 2023)
K221963 — Cumulus Functional Neurophysiology Platform (April 27, 2023)
K230073 — Okti (February 9, 2023)
K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
K220056 — iSyncWave (August 10, 2022)
K212788 — Seer Home (June 16, 2022)