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FDA 510(k)

MODEL 621/624 BIOMAGNETOMETER

K-Number: K151135 · 2016-03-15

ApplicantTristan Technologies, Inc.
Decision Date2016-03-15
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 621/624 BIOMAGNETOMETER 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 2016-03-15 under 510(k) 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. The listed applicant is Tristan Technologies, Inc.. The 510(k) number is K151135.

When did MODEL 621/624 BIOMAGNETOMETER receive FDA 510(k) clearance?

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

Who is the listed applicant for MODEL 621/624 BIOMAGNETOMETER?

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 MODEL 621/624 BIOMAGNETOMETER?

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

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.

K152184MagView BIOMAGNETOMETER SYSTEM

Related Devices (Code: DPS)

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.

K252463SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E)Edan Instruments, Inc.K251670MAC 7 Resting ECG Analysis SystemGe Medical Systems Information Technologies, Inc.K252361AccurECG Analysis System (v2.0)Accurkardia, Inc.K252474Withings BeamO (SCT02)WithingsK250569Cardiologs Holter PlatformPhilips France CommercialK243252ZBPro DiagnosticZbeats, Inc.

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.

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