Cleared Traditional

EL2-SERIES BLOOD COLLECTION REERVOIR

K930154 · Electromedics, Inc. · Cardiovascular
Jul 1993
Decision
169d
Days
Class 2
Risk

About This 510(k) Submission

K930154 is an FDA 510(k) clearance for the EL2-SERIES BLOOD COLLECTION REERVOIR, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Electromedics, Inc. (Englewood, US). The FDA issued a Cleared decision on July 1, 1993, 169 days after receiving the submission on January 13, 1993. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.

Submission Details

510(k) Number K930154 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 1993
Decision Date July 01, 1993
Days to Decision 169 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTN — Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4400

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