Home / 510(k) Clearances / K191785

510(k) K191785

Orion LifeSpan MEG by Compumedics Limited — Product Code OLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2020
Date Received
July 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Magnetoencephalograph
Device Class
Class II
Regulation Number
882.1400
Review Panel
NE
Submission Type

Acquire, display, store, and archive biomagnetic signals produced by electrically active nerve tissue in the brain to provide information about the location of active nerve tissue responsible for certain brain functions relative to brain anatomy.

Other clearances by Compumedics Limited

  • K252383 — Somfit D (August 28, 2025)
  • K242447 — Falcon HST (February 20, 2025)
  • K231546 — Somfit (November 30, 2023)
  • K230073 — Okti (February 9, 2023)
  • K093223 — COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG (January 15, 2010)
  • K072201 — COMPUMEDICS SOMTE PSG RECORDING SYSTEM (April 14, 2008)
  • K021176 — COMPUMEDICS SOMTE SYSTEM (January 21, 2003)
  • K003175 — COMPUMEDICS SIESTA SYSTEM (December 27, 2000)

Other clearances for product code OLY

  • K152184 — MagView BIOMAGNETOMETER SYSTEM (April 8, 2016)
  • K133419 — BABYMEG BIOMAGNETOMETER SYSTEM (July 21, 2014)
  • K962317 — MAGNES 2500 WH BIOMAGNETOMETER (May 7, 1997)
  • K962764 — NEUROMAG-122 (October 31, 1996)
  • K854466 — BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER (February 4, 1986)