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FDA 510(k)

SLEUTH IMPLANTABLE ECG MONITORING SYSTEM

K-Number: K063035 · 2007-10-01

ApplicantTransnoma Medical, Inc.
Decision Date2007-10-01
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SLEUTH IMPLANTABLE ECG MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Transnoma Medical, Inc.. It received FDA 510(k) clearance on 2007-10-01 under 510(k) number K063035. The device is classified under product code MXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEUTH IMPLANTABLE ECG MONITORING SYSTEM?

SLEUTH IMPLANTABLE ECG MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-10-01. The listed applicant is Transnoma Medical, Inc.. The 510(k) number is K063035.

When did SLEUTH IMPLANTABLE ECG MONITORING SYSTEM receive FDA 510(k) clearance?

SLEUTH IMPLANTABLE ECG MONITORING SYSTEM received FDA 510(k) clearance on 2007-10-01, under 510(k) number K063035.

Who is the listed applicant for SLEUTH IMPLANTABLE ECG MONITORING SYSTEM?

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

What is the FDA product code for SLEUTH IMPLANTABLE ECG MONITORING SYSTEM?

The FDA product code for SLEUTH IMPLANTABLE ECG MONITORING SYSTEM is MXC.

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Related Devices (Code: MXC)

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Official Source

View on FDA Database →

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

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