FDA 510(k)

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)

K-Nummer: K193310 · 2020-03-17

Entscheidungsdatum2020-03-17

ProduktcodeMXC

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) is the device name listed in this FDA 510(k) record. The listed applicant is Abbott (St. Jude Medical). It received FDA 510(k) clearance on 2020-03-17 under 510(k) number K193310. The device is classified under product code MXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)?

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) is a medical device that received FDA 510(k) clearance on 2020-03-17. The listed applicant is Abbott (St. Jude Medical). The 510(k) number is K193310.

When did myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) receive FDA 510(k) clearance?

myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) received FDA 510(k) clearance on 2020-03-17, under 510(k) number K193310.

Who is the listed applicant for myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)?

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

What is the FDA product code for myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS)?

The FDA product code for myMerlin Mobile Application (Android), myMerlin Mobile Application (iOS) is MXC.

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Weitere Einträge mit Abbott (St. Jude Medical) als Antragsteller

K212206Jot Dx Insertable Cardiac Monitor K202876Confirm Rx Insertable Cardiac Monitor K202888Confirm Rx Insertable Cardiac Monitor K200721Agilis HisPro Steerable Catheter With Electrodes K190295Confirm Rx Insertable Cardiac Monitor

Verwandte Geräte (Code: MXC)

K230286Assert-IQ™ Insertable Cardiac MonitorABBOTT MEDICAL K212206Jot Dx Insertable Cardiac MonitorAbbott (St. Jude Medical)K202876Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)K202888Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)K192593Confirm Rx Insertable Cardiac MonitorAbbott K190295Confirm Rx Insertable Cardiac MonitorAbbott (St. Jude Medical)

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