510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K133419Substantially Equivalent

Babymeg Biomagnetometer System

Tristan Technologies, Inc., Encinitas CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K133419 is the FDA 510(k) clearance record for BABYMEG BIOMAGNETOMETER SYSTEM, a class II device, cleared for Tristan Technologies, Inc. on under FDA product code OLY (Magnetoencephalograph). FDA's definition for product code OLY reads: "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...". FDA records list 3 510(k) clearances for Tristan Technologies, Inc., from to . As of , FDA records show no recalls naming K133419.

Clearance record

Decision date
Received
(256 days to decision)
Product code
OLY Magnetoencephalograph
Regulation
21 CFR 882.1400
Device class
Class II
Review panel
Neurology
Applicant
Tristan Technologies, Inc. 3365 Calle Margarita, Encinitas CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OLY

Trailing 12 months

FDA records hold no clearances under product code OLY in the trailing twelve months.

FDA records show no clearances under product code OLY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OLY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260