510(k) K901549

CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE. by Cns, Inc. — Product Code GWQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 24, 1990
Date Received: April 3, 1990
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 Cns, Inc.

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K954914 — BREATHE RIGHT NASAL STRIP (February 27, 1996)
K953772 — BREATHE RIGHT NASAL STRIP (October 20, 1995)
K950273 — SLEEP TEST(TM) (September 19, 1995)
K921220 — BREATHE RIGHT (October 7, 1993)
K912436 — AM-PAK (October 18, 1991)
K904432 — SLEEP I/T-5 AND SLEEP I/T-8 (July 10, 1991)
K910452 — RESPI-PAK RT-PAK (April 16, 1991)
K897107 — POLY G PHYSIOLOGICAL DATA RECORDER (March 12, 1990)
K860829 — CNS 4/8 AND CT 48.1 SOFTWARE (May 29, 1986)

Other clearances for product code GWQ

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K231366 — Neuronaute Plus (November 9, 2023)
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K221963 — Cumulus Functional Neurophysiology Platform (April 27, 2023)
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K223644 — Neuronaute with IceCap 2 & IceCap 2 Small (January 12, 2023)
K220056 — iSyncWave (August 10, 2022)
K212788 — Seer Home (June 16, 2022)