Cleared Traditional

K924894 - AUTOVAC 7900 SERIES (FDA 510(k) Clearance)

K924894 · Boehringer Laboratories · Anesthesiology device

Feb 1993

Decision

130d

Days

Class 2

Risk

K924894 is an FDA 510(k) clearance for the AUTOVAC 7900 SERIES. This device is classified as a Apparatus, Autotransfusion (Class II - Special Controls, product code CAC).

Submitted by Boehringer Laboratories (Norristown, US). The FDA issued a Cleared decision on February 5, 1993, 130 days after receiving the submission on September 28, 1992.

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

Submission Details

510(k) Number	K924894 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 28, 1992
Decision Date	February 05, 1993
Days to Decision	130 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF