Cleared Traditional

K873807 - AUTOTRANSFUSION APPARATUS
(FDA 510(k) Clearance)

K873807 · Biodynamics Corp. · Anesthesiology

Mar 1988

Decision

173d

Days

Class 2

Risk

K873807 is an FDA 510(k) clearance for the AUTOTRANSFUSION APPARATUS. This device is classified as a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC).

Submitted by Biodynamics Corp. (Houston, US). The FDA issued a Cleared decision on March 9, 1988, 173 days after receiving the submission on September 18, 1987.

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

Submission Details

510(k) Number	K873807 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 1987
Decision Date	March 09, 1988
Days to Decision	173 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—