Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor— 510(k) K151781

Name: FDA 510(k) clearance K151781
Creator: U.S. Food and Drug Administration
Published: 2016-05-27

Substantially Equivalent

Ivy Biomedical Systems, Inc.

FDA 510(k) clearance K151781 for Cardiac Trigger Monitor, Cardiac & Regulatory Synchronization Monitor, Substantially Equivalent on 2016-05-27. Applicant: Ivy Biomedical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ivy Biomedical Systems, Inc.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 2015-07-01
Decision date: 2016-05-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Branford, CT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.