Cleared Traditional

Cardiac Trigger Monitor

K202138 · Ivy Biomedical Systems, Inc. · Cardiovascular
May 2021
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K202138 is an FDA 510(k) clearance for the Cardiac Trigger Monitor, a Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (Class II — Special Controls, product code DRT), submitted by Ivy Biomedical Systems, Inc. (Branford, US). The FDA issued a Cleared decision on May 14, 2021, 287 days after receiving the submission on July 31, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K202138 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2020
Decision Date May 14, 2021
Days to Decision 287 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300

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