FDA 510(k)

MagView BIOMAGNETOMETER SYSTEM

K-Number: K152184 · 2016-04-08

Decision Date2016-04-08

Product CodeOLY

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MagView BIOMAGNETOMETER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Tristan Technologies, Inc.. It received FDA 510(k) clearance on 2016-04-08 under 510(k) number K152184. The device is classified under product code OLY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MagView BIOMAGNETOMETER SYSTEM?

MagView BIOMAGNETOMETER SYSTEM is a medical device that received FDA 510(k) clearance on 2016-04-08. The listed applicant is Tristan Technologies, Inc.. The 510(k) number is K152184.

When did MagView BIOMAGNETOMETER SYSTEM receive FDA 510(k) clearance?

MagView BIOMAGNETOMETER SYSTEM received FDA 510(k) clearance on 2016-04-08, under 510(k) number K152184.

Who is the listed applicant for MagView BIOMAGNETOMETER SYSTEM?

The FDA 510(k) record lists Tristan Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MagView BIOMAGNETOMETER SYSTEM?

The FDA product code for MagView BIOMAGNETOMETER SYSTEM is OLY.

Other records listing Tristan Technologies, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K151135MODEL 621/624 BIOMAGNETOMETER

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Official Source

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