Cleared Traditional

HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR

K874605 · Mallinckrodt Critical Care · Cardiovascular
Feb 1988
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K874605 is an FDA 510(k) clearance for the HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR, a Accessory Equipment, Cardiopulmonary Bypass (Class I — General Controls, product code KRI), submitted by Mallinckrodt Critical Care (Argyle, US). The FDA issued a Cleared decision on February 2, 1988, 85 days after receiving the submission on November 9, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4200.

Submission Details

510(k) Number K874605 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 1987
Decision Date February 02, 1988
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code KRI — Accessory Equipment, Cardiopulmonary Bypass
Device Class Class I — General Controls
CFR Regulation 21 CFR 870.4200

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