Cleared Special

K110987 - CARDIAC TRIGGER MONITOR (FDA 510(k) Clearance)

K110987 · Ivy Biomedical Systems, Inc. · Cardiovascular device
Jul 2011
Decision
105d
Days
Class 2
Risk

K110987 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 July 22, 2011, 105 days after receiving the submission on April 8, 2011.

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

Submission Details

510(k) Number K110987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 2011
Decision Date July 22, 2011
Days to Decision 105 days
Submission Type Special
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