Cleared Traditional

K884455 - MODEL 702 ECG/RESPIRATION/TEMPERATURE (FDA 510(k) Clearance)

K884455 · Ivy Biomedical Systems, Inc. · Cardiovascular device
Mar 1989
Decision
136d
Days
Class 2
Risk

K884455 is an FDA 510(k) clearance for the MODEL 702 ECG/RESPIRATION/TEMPERATURE. 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 March 9, 1989, 136 days after receiving the submission on October 24, 1988.

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

Submission Details

510(k) Number K884455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1988
Decision Date March 09, 1989
Days to Decision 136 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