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FDA 510(k)

SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08

K-Number: K073147 · 2007-12-03

ApplicantTransoma Medical
Decision Date2007-12-03
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 is the device name listed in this FDA 510(k) record. The listed applicant is Transoma Medical. It received FDA 510(k) clearance on 2007-12-03 under 510(k) number K073147. 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 SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08?

SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 is a medical device that received FDA 510(k) clearance on 2007-12-03. The listed applicant is Transoma Medical. The 510(k) number is K073147.

When did SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 receive FDA 510(k) clearance?

SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 received FDA 510(k) clearance on 2007-12-03, under 510(k) number K073147.

Who is the listed applicant for SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08?

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

What is the FDA product code for SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08?

The FDA product code for SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08 is MXC.

Related Clinical Trials

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.

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Other records listing Transoma Medical 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.

K091206SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL

Related Devices (Code: MXC)

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.

K230286Assert-IQ™ Insertable Cardiac MonitorABBOTT MEDICALK212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical)K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)K202888Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)K193310myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)Abbott (St. Jude Medical)K192593Confirm Rx Insertable Cardiac MonitorAbbott

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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