Cleared Special

Jot Dx Insertable Cardiac Monitor

K212206 · Abbott (St. Jude Medical) · Cardiovascular

Aug 2021

Decision

29d

Days

Class 2

Risk

About This 510(k) Submission

K212206 is an FDA 510(k) clearance for the Jot Dx Insertable Cardiac Monitor, a Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection) (Class II — Special Controls, product code MXC), submitted by Abbott (St. Jude Medical) (Sylmar, US). The FDA issued a Cleared decision on August 13, 2021, 29 days after receiving the submission on July 15, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number	K212206 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 15, 2021
Decision Date	August 13, 2021
Days to Decision	29 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MXC — Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2800