Cleared Traditional

K955010 - AUTOVAC BP SYSTE, 2000 SERIES (FDA 510(k) Clearance)

K955010 · Boehringer Laboratories · Anesthesiology device

Jun 1996

Decision

232d

Days

Class 2

Risk

K955010 is an FDA 510(k) clearance for the AUTOVAC BP SYSTE, 2000 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 June 20, 1996, 232 days after receiving the submission on November 1, 1995.

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

Submission Details

510(k) Number	K955010 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 01, 1995
Decision Date	June 20, 1996
Days to Decision	232 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement