Cleared Traditional

K934355 - ELECTROMEDICS BLOOD HEAT EXCHANGER
(FDA 510(k) Clearance)

K934355 · Electromedics, Inc. · Cardiovascular
Dec 1993
Decision
87d
Days
Class 2
Risk

K934355 is an FDA 510(k) clearance for the ELECTROMEDICS BLOOD HEAT EXCHANGER, a Heat-exchanger, Cardiopulmonary Bypass (Class II — Special Controls, product code DTR), submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on December 3, 1993, 87 days after receiving the submission on September 7, 1993. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4240.

Submission Details

510(k) Number K934355 FDA.gov
FDA Decision Cleared SESE
Date Received September 07, 1993
Decision Date December 03, 1993
Days to Decision 87 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code DTR — Heat-exchanger, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4240

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