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FDA 510(k)

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

K-Number: K091206 · 2009-05-18

ApplicantTransoma Medical
Decision Date2009-05-18
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL is the device name listed in this FDA 510(k) record. The listed applicant is Transoma Medical. It received FDA 510(k) clearance on 2009-05-18 under 510(k) number K091206. 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 AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL?

SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL is a medical device that received FDA 510(k) clearance on 2009-05-18. The listed applicant is Transoma Medical. The 510(k) number is K091206.

When did SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL receive FDA 510(k) clearance?

SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL received FDA 510(k) clearance on 2009-05-18, under 510(k) number K091206.

Who is the listed applicant for SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL?

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

The FDA product code for SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM-6 AND 8CM ANTENNA, PERSONAL DIAGNOSTIC MANAGER(PDM) ACCESSORY KIT, MODEL 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.

K073147SLEUTH IMPLANTABLE ECG SYSTEM-8 CM ACCESSORY KIT, MODEL 3000-08

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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