Cleared Traditional

K935977 - SARNS AIR DETECTION SYSTEM
(FDA 510(k) Clearance)

K935977 · 3M Health Care, Sarns · Cardiovascular

Feb 1994

Decision

53d

Days

Class 2

Risk

K935977 is an FDA 510(k) clearance for the SARNS AIR DETECTION SYSTEM, 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 February 4, 1994, 53 days after receiving the submission on December 13, 1993. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4205.

Submission Details

510(k) Number	K935977 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 1993
Decision Date	February 04, 1994
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF