Cleared Abbreviated

K170828 - Cardiac Trigger Monitor (FDA 510(k) Clearance)

K170828 · Ivy Biomedical Systems, Inc. · Cardiovascular device
May 2017
Decision
58d
Days
Class 2
Risk

K170828 is an FDA 510(k) clearance for the Cardiac Trigger Monitor. This device is classified as 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 17, 2017, 58 days after receiving the submission on March 20, 2017.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K170828 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2017
Decision Date May 17, 2017
Days to Decision 58 days
Submission Type Abbreviated
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