Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Jot Dx Insertable Cardiac Monitor

K-Number: K212206 · 2021-08-13

ApplicantAbbott (St. Jude Medical)
Decision Date2021-08-13
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Jot Dx Insertable Cardiac Monitor is a medical device manufactured by Abbott (St. Jude Medical). It received FDA 510(k) clearance on 2021-08-13 under approval number K212206. 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 Jot Dx Insertable Cardiac Monitor?

Jot Dx Insertable Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2021-08-13. It is manufactured by Abbott (St. Jude Medical). The 510(k) number is K212206.

When was Jot Dx Insertable Cardiac Monitor approved by the FDA?

Jot Dx Insertable Cardiac Monitor received FDA 510(k) clearance on 2021-08-13, under approval number K212206.

What company makes Jot Dx Insertable Cardiac Monitor?

Jot Dx Insertable Cardiac Monitor is manufactured by Abbott (St. Jude Medical).

What is the FDA product code for Jot Dx Insertable Cardiac Monitor?

The FDA product code for Jot Dx Insertable Cardiac Monitor is MXC.

Related Clinical Trials

NCT06232876 Continuous Versus Intermittent Ward Monitoring NOT_YET_RECRUITING NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT06172699 Assert-IQ Implantable Cardiac Monitor (ICM) Post Market Study COMPLETED NCT07405333 Effect of Coughing Exercises Versus Incentive Spirometry on Respiratory Function and Recovery in Children After Cardiac Surgery. RECRUITING NCT06589700 B2AD-Risk AFDAS Evolution of Burden of AF RECRUITING NCT03505801 Confirm Rx Insertable Cardiac Monitor SMART Registry COMPLETED

Other Devices by Abbott (St. Jude Medical)

K190295Confirm Rx Insertable Cardiac Monitor K202876Confirm Rx Insertable Cardiac Monitor K202888Confirm Rx Insertable Cardiac Monitor K200721Agilis HisPro Steerable Catheter With Electrodes K193310myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)

Related Devices (Code: MXC)

K173232myMerlin(TM) Mobile Application Model APP1001St Jude Medical K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. K192593Confirm Rx Insertable Cardiac MonitorAbbott K190295Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) K182981Confirm Rx Insertable Cardiac MonitorAbbott K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)

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.

↑