Cleared Traditional

LEVEL 1 BLOOD STREAM RECOVERY SYSTEM

K942844 · Level 1 Technologies, Inc. · Anesthesiology
Apr 1996
Decision
680d
Days
Class 2
Risk

About This 510(k) Submission

K942844 is an FDA 510(k) clearance for the LEVEL 1 BLOOD STREAM RECOVERY SYSTEM, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Level 1 Technologies, Inc. (Rockland, US). The FDA issued a Cleared decision on April 26, 1996, 680 days after receiving the submission on June 16, 1994. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K942844 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 1994
Decision Date April 26, 1996
Days to Decision 680 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAC — Apparatus, Autotransfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5830

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