510(k) K923894

YHE GALILEO PLEIADE ELECTROENCEPHALOGRAPH by Biosound, Inc. — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 10, 1993
Date Received: August 4, 1992
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 Biosound, Inc.

K971700 — BIOPSY ACCESSORY FOR ULTRASOUND TRANSDUCER (July 9, 1997)
K963936 — ACCESSPOINT, MED E-MAIL, DICOM READER (March 31, 1997)
K963262 — ARTOSCAN M (March 28, 1997)
K963662 — GALILEO EVOKED POTENTIALRE (February 26, 1997)
K953716 — INTRACAVITY TRANSDUCERS (April 17, 1996)
K953530 — DIAGNOSTIC ULTRASOUND TRANDUCERS P10A, P12A, PT10A, PA11-A (April 8, 1996)
K953819 — DIAGNOSTIC ULTRASOUND TRANDUCER (March 1, 1996)
K953759 — DIAGNOSTIC ULTRASOUND TRANSDUCER (March 1, 1996)
K955458 — ULTRASOUND PROBE BIOPSY ACCESSORIES (February 12, 1996)
K953579 — TEE PROBE (February 2, 1996)

Other clearances for product code GWQ

K260455 — New Wave System (March 13, 2026)
K233403 — Flexset System (April 30, 2024)
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)