Cleared Traditional

DAVOL ATS

K931899 · Davol, Inc. · Anesthesiology
Nov 1994
Decision
575d
Days
Class 2
Risk

About This 510(k) Submission

K931899 is an FDA 510(k) clearance for the DAVOL ATS, 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, 1994, 575 days after receiving the submission on April 19, 1993. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K931899 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1993
Decision Date November 15, 1994
Days to Decision 575 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAC — Apparatus, Autotransfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5830

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