Cleared Special

K023616 - PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) (FDA 510(k) Clearance)

K023616 · Ivy Biomedical Systems, Inc. · Cardiovascular device
Nov 2002
Decision
6d
Days
Class 2
Risk

K023616 is an FDA 510(k) clearance for the PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES). 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 November 4, 2002, 6 days after receiving the submission on October 29, 2002.

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

Submission Details

510(k) Number K023616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2002
Decision Date November 04, 2002
Days to Decision 6 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