Cleared Traditional

K913684 - DAVOL POST-OP AUTOTRANSFUSION SYSTEM (FDA 510(k) Clearance)

K913684 · Davol, Inc. · Anesthesiology device

Nov 1991

Decision

88d

Days

Class 2

Risk

K913684 is an FDA 510(k) clearance for the DAVOL POST-OP AUTOTRANSFUSION 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 November 15, 1991, 88 days after receiving the submission on August 19, 1991.

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

Submission Details

510(k) Number	K913684 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 19, 1991
Decision Date	November 15, 1991
Days to Decision	88 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF