Cleared Traditional

K884096 - PATIENT MONITOR MODEL 701 (FDA 510(k) Clearance)

K884096 · Ivy Biomedical Systems, Inc. · Cardiovascular device
Feb 1989
Decision
148d
Days
Class 2
Risk

K884096 is an FDA 510(k) clearance for the PATIENT MONITOR MODEL 701. 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 February 23, 1989, 148 days after receiving the submission on September 28, 1988.

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

Submission Details

510(k) Number K884096 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 1988
Decision Date February 23, 1989
Days to Decision 148 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DRT — Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class II - Special Controls
CFR Regulation 21 CFR 870.2300