Cleared Traditional

IN-LINE OXYGEN MONITORING SYSTEM

K821159 · G.D. Searle and Co. · Cardiovascular
May 1982
Decision
33d
Days
Class 2
Risk

About This 510(k) Submission

K821159 is an FDA 510(k) clearance for the IN-LINE OXYGEN MONITORING SYSTEM, a Monitor, Blood-gas, On-line, Cardiopulmonary Bypass (Class II — Special Controls, product code DRY), submitted by G.D. Searle and Co. (Walker, US). The FDA issued a Cleared decision on May 25, 1982, 33 days after receiving the submission on April 22, 1982. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4330.

Submission Details

510(k) Number K821159 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1982
Decision Date May 25, 1982
Days to Decision 33 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DRY — Monitor, Blood-gas, On-line, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4330

Similar Devices — DRY Monitor, Blood-gas, On-line, Cardiopulmonary Bypass

All 46
CDI OneView Monitoring System
K234065 · Terumo Cardiovascular Systems Corporation · Apr 2024
B-Capta
K202154 · Livanova Deutschland, GmbH · Apr 2021
Quantum Workstation 12 Elite
K202557 · Spectrum Medical , Ltd. · Oct 2020
CDI Blood Parameter Monitoring System 550
K182110 · Terumo Cardiovascular Systems Corporation · Nov 2018
Quantum Workstation 12.1
K181923 · Spectrum Medical , Ltd. · Aug 2018
Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
K173591 · Spectrum Medical , Ltd. · Mar 2018