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510(k) K100683

NEUROLINK IP MODEL: PK1117 by Natus Medical Incorporated — Product Code GWQ

K100683 is an FDA 510(k) premarket notification submitted by Natus Medical Incorporated for the device "NEUROLINK IP MODEL: PK1117". The FDA issued a decision of Substantially Equivalent on April 9, 2010. The device falls under product code GWQ (Full-Montage Standard Electroencephalograph), a Class II device regulated under 21 CFR 882.1400. Natus Medical Incorporated has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 9, 2010
Date Received
March 10, 2010
Clearance Type
Special
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 Natus Medical Incorporated

  • K182178 — neoBLUE blanket LED Phototherapy System (December 13, 2018)
  • K182263 — RetCam 3 ; RetCam Shuttle ; RetCam Portable (September 7, 2018)
  • K160745 — neoBLUE compact LED Phototherapy System (December 12, 2016)
  • K160305 — neoBLUE® LED Phototherapy System (May 27, 2016)
  • K143440 — Natus Quantum (April 20, 2015)
  • K141446 — ECHO-SCREEN III PRO HEARING SCREENER WITH BARCODE SCANNER, ECHO-SCREEN III PRO H (August 22, 2014)
  • K112247 — A BAER WITH ABAER I/O FUNCTION (April 2, 2012)
  • K111618 — AUDX OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM WITH AUDX I/O FUNCTION (December 28, 2011)
  • K103589 — NEOBLUE BLANKET LED PHOTOTHERAPY SYSTEM (May 13, 2011)

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