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FDA 510(k)

Confirm Rx Insertable Cardiac Monitor

K-Number: K192593 · 2019-10-18

ApplicantAbbott
Decision Date2019-10-18
Product CodeMXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Confirm Rx Insertable Cardiac Monitor is a medical device manufactured by Abbott. It received FDA 510(k) clearance on 2019-10-18 under approval number K192593. 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 Confirm Rx Insertable Cardiac Monitor?

Confirm Rx Insertable Cardiac Monitor is a medical device that received FDA 510(k) clearance on 2019-10-18. It is manufactured by Abbott. The 510(k) number is K192593.

When was Confirm Rx Insertable Cardiac Monitor approved by the FDA?

Confirm Rx Insertable Cardiac Monitor received FDA 510(k) clearance on 2019-10-18, under approval number K192593.

What company makes Confirm Rx Insertable Cardiac Monitor?

Confirm Rx Insertable Cardiac Monitor is manufactured by Abbott.

What is the FDA product code for Confirm Rx Insertable Cardiac Monitor?

The FDA product code for Confirm Rx Insertable Cardiac Monitor is MXC.

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Related Devices (Code: MXC)

K173232myMerlin(TM) Mobile Application Model APP1001St Jude Medical K163407Confirm Rx Insertable Cardiac Monitor (ICM) SystemSt. Jude Medical, Inc. K190295Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) K182981Confirm Rx Insertable Cardiac MonitorAbbott K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical) K202888Confirm 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.

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