Cleared Traditional

SARNS ULTRASONIC AIR SENSOR

K940651 · 3M Health Care, Sarns · Cardiovascular
May 1994
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K940651 is an FDA 510(k) clearance for the SARNS ULTRASONIC AIR SENSOR, a Detector, Bubble, Cardiopulmonary Bypass (Class II — Special Controls, product code KRL), submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on May 24, 1994, 98 days after receiving the submission on February 15, 1994. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4205.

Submission Details

510(k) Number K940651 FDA.gov
FDA Decision Cleared SESE
Date Received February 15, 1994
Decision Date May 24, 1994
Days to Decision 98 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

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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