Cleared Traditional

K895297 - AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION (FDA 510(k) Clearance)

K895297 · Boehringer Laboratories · Anesthesiology device

Mar 1990

Decision

200d

Days

Class 2

Risk

K895297 is an FDA 510(k) clearance for the AUTOTRANSFUSION RESERVIOR MODEL 7900 MODIFICATION. 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 March 13, 1990, 200 days after receiving the submission on August 25, 1989.

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

Submission Details

510(k) Number	K895297 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 25, 1989
Decision Date	March 13, 1990
Days to Decision	200 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—