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FDA 510(k)

SJM CONFIRM IMPLANTABLE CARDIAC MONITOR

K-Number: K122090 · 2012-11-15

ApplicantSt. Jude Medical, Cardiac Rhythm Management Divisi
Decision Date2012-11-15
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SJM CONFIRM IMPLANTABLE CARDIAC MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Cardiac Rhythm Management Divisi. It received FDA 510(k) clearance on 2012-11-15 under 510(k) number K122090. 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 SJM CONFIRM IMPLANTABLE CARDIAC MONITOR?

SJM CONFIRM IMPLANTABLE CARDIAC MONITOR is a medical device that received FDA 510(k) clearance on 2012-11-15. The listed applicant is St. Jude Medical, Cardiac Rhythm Management Divisi. The 510(k) number is K122090.

When did SJM CONFIRM IMPLANTABLE CARDIAC MONITOR receive FDA 510(k) clearance?

SJM CONFIRM IMPLANTABLE CARDIAC MONITOR received FDA 510(k) clearance on 2012-11-15, under 510(k) number K122090.

Who is the listed applicant for SJM CONFIRM IMPLANTABLE CARDIAC MONITOR?

The FDA 510(k) record lists St. Jude Medical, Cardiac Rhythm Management Divisi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SJM CONFIRM IMPLANTABLE CARDIAC MONITOR?

The FDA product code for SJM CONFIRM IMPLANTABLE CARDIAC MONITOR is MXC.

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Other records listing St. Jude Medical, Cardiac Rhythm Management Divisi as applicant

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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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