Cleared Traditional

K901401 - DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM (FDA 510(k) Clearance)

K901401 · Davol, Inc. · Anesthesiology device

Oct 1990

Decision

211d

Days

Class 2

Risk

K901401 is an FDA 510(k) clearance for the DAVOL AUTOTRANSFUSION BLOOD PROCESSING SYSTEM. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).

Submitted by Davol, Inc. (Cranston, US). The FDA issued a Cleared decision on October 23, 1990, 211 days after receiving the submission on March 26, 1990.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number	K901401 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 26, 1990
Decision Date	October 23, 1990
Days to Decision	211 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—