Model 621/624 Biomagnetometer

FDA 510(k) K151135 · Tristan Technologies, Inc.

Substantially Equivalent

510(k) numberK151135

Submission

Device name
Model 621/624 Biomagnetometer
Applicant
Tristan Technologies, Inc.
San Diego, CA, US
Received
April 29, 2015
Decision date
March 15, 2016
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DPS – Electrocardiograph
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2340
Specialty
Cardiovascular

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Questions and answers

When was Model 621/624 Biomagnetometer cleared by the FDA?

Model 621/624 Biomagnetometer (K151135) received a 510(k) decision of Substantially Equivalent on March 15, 2016, 321 days after the submission was received.

What is the product code of K151135?

The FDA product code is DPS – Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2340.