DRT · Class II · 21 CFR 870.2300

FDA Product Code DRT: Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

Leading manufacturers include Ivy Biomedical Systems, Inc..

1
Total
1
Cleared
287d
Avg days
2021
Since

List of Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) devices cleared through 510(k)

1 devices
1–1 of 1
Cleared May 14, 2021
Cardiac Trigger Monitor
K202138
Ivy Biomedical Systems, Inc.
Cardiovascular · 287d

How to use this database

This page lists all FDA 510(k) submissions for Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) devices (product code DRT). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →