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510(k) K901549

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

K901549 is an FDA 510(k) premarket notification submitted by Cns, Inc. for the device "CNS SATELLITE 100, 200, 1000, 2000 ELECTROENCE.". The FDA issued a decision of Substantially Equivalent on October 24, 1990. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Cns, Inc. has at least 10 other 510(k) clearances on record.

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.

  • K955711 — BREATHE RIGHT NASAL STRIP (May 30, 1996)
  • 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

  • K261604 — Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32) (June 13, 2026)
  • 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)

FDA data resources