FDA 510(k)

MODEL 621/624 BIOMAGNETOMETER

K-Number: K151135 · 2016-03-15

Decision Date2016-03-15

Product CodeDPS

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

MODEL 621/624 BIOMAGNETOMETER is a medical device manufactured by Tristan Technologies, Inc.. It received FDA 510(k) clearance on 2016-03-15 under approval number K151135. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 621/624 BIOMAGNETOMETER?

MODEL 621/624 BIOMAGNETOMETER is a medical device that received FDA 510(k) clearance on 2016-03-15. It is manufactured by Tristan Technologies, Inc.. The 510(k) number is K151135.

When was MODEL 621/624 BIOMAGNETOMETER approved by the FDA?

MODEL 621/624 BIOMAGNETOMETER received FDA 510(k) clearance on 2016-03-15, under approval number K151135.

What company makes MODEL 621/624 BIOMAGNETOMETER?

MODEL 621/624 BIOMAGNETOMETER is manufactured by Tristan Technologies, Inc..

What is the FDA product code for MODEL 621/624 BIOMAGNETOMETER?

The FDA product code for MODEL 621/624 BIOMAGNETOMETER is DPS.

Other Devices by Tristan Technologies, Inc.

K152184MagView BIOMAGNETOMETER SYSTEM

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K160746CARDIOLINE touchECGCardioline S.P.A K160840ECG100+, ECG200+Cardioline S.P.A K152135Quantitative Electrocardiographic Detector (QED 2000)Acme Portable Machines, Inc. K161302PC ECGEdan Instruments, Inc. K152863Portable ECG MonitorContec Medical Systems Co.,Ltd K152043Diagnostic Station DS20Schiller AG

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.