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510(k) K133419

BABYMEG BIOMAGNETOMETER SYSTEM by Tristan Technologies, Inc. — Product Code OLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 2014
Date Received
November 7, 2013
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 Tristan Technologies, Inc.

  • K152184 — MagView BIOMAGNETOMETER SYSTEM (April 8, 2016)
  • K151135 — MODEL 621/624 BIOMAGNETOMETER (March 15, 2016)

Other clearances for product code OLY

  • K191785 — Orion LifeSpan MEG (February 14, 2020)
  • K152184 — MagView BIOMAGNETOMETER SYSTEM (April 8, 2016)
  • K962317 — MAGNES 2500 WH BIOMAGNETOMETER (May 7, 1997)
  • K962764 — NEUROMAG-122 (October 31, 1996)
  • K854466 — BIOMAGNETIC TECHNOLOGIES NEUROMAGNEOMETER (February 4, 1986)