BABYMEG BIOMAGNETOMETER SYSTEM— 510(k) K133419

Name: FDA 510(k) clearance K133419
Creator: U.S. Food and Drug Administration
Published: 2014-07-21

Substantially Equivalent

Tristan Technologies, Inc.

FDA 510(k) clearance K133419 for BABYMEG BIOMAGNETOMETER SYSTEM, Substantially Equivalent on 2014-07-21. Applicant: Tristan Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Tristan Technologies, Inc.
Product code: Code OLY
Device class: Class 2
Regulation: 21 CFR 882.1400
Advisory panel: Neurology
Date received: 2013-11-07
Decision date: 2014-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Encinitas, CA, US

Download summary PDF View on FDA.gov ↗

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