Cleared Traditional

ELS AUTOMATIC TUBING CLAMP SYSTEM

K961598 · Rocky Mountain Research, Inc. · Cardiovascular
Oct 1996
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K961598 is an FDA 510(k) clearance for the ELS AUTOMATIC TUBING CLAMP SYSTEM, a Detector, Bubble, Cardiopulmonary Bypass (Class II — Special Controls, product code KRL), submitted by Rocky Mountain Research, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on October 29, 1996, 203 days after receiving the submission on April 9, 1996. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4205.

Submission Details

510(k) Number K961598 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1996
Decision Date October 29, 1996
Days to Decision 203 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code KRL — Detector, Bubble, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4205

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