510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993708Substantially Equivalent

Biomagnetic Technologies Magnes 3600 Whole Head Meg

Biomagnetic Technologies, Inc., San Diego CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K993708 is the FDA 510(k) clearance record for BIOMAGNETIC TECHNOLOGIES MAGNES 3600 WHOLE HEAD MEG, a class II device, cleared for Biomagnetic Technologies, Inc. on under FDA product code OLX (Source Localization Software For Electroencephalograph Or Magnetoencephalograph). FDA's definition for product code OLX reads: "Correlation of electrical activity of the brain using various neuroimaging modalities for source-localization". FDA records list 8 510(k) clearances for Biomagnetic Technologies, Inc., from to . As of , FDA records show no recalls naming K993708.

Clearance record

Decision date
Received
(30 days to decision)
Product code
OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Biomagnetic Technologies, Inc. 9727 Pacific Heights Blvd., San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code OLX

Trailing 12 months
2 clearances under product code OLX in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code OLX, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260