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510(k) K962317

MAGNES 2500 WH BIOMAGNETOMETER by Biomagnetic Technologies, Inc. — Product Code OLY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1997
Date Received
June 17, 1996
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.

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  • K913604 — SOMATOSENSORY STIMULUS SYSTEM (December 9, 1991)
  • K901215 — 700 SERIES BIOMAGNETOMETER (June 25, 1990)
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Other clearances for product code OLY

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  • K962764 — NEUROMAG-122 (October 31, 1996)
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