Cleared Traditional

IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE

K915577 · Impra, Inc. · General Hospital

Mar 1992

Decision

89d

Days

Class 2

Risk

About This 510(k) Submission

K915577 is an FDA 510(k) clearance for the IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE, a Monitor, Spinal-fluid Pressure, Electrically Powered (Class II — Special Controls, product code CAR), submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on March 11, 1992, 89 days after receiving the submission on December 13, 1991. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2460.

Submission Details

510(k) Number	K915577 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 1991
Decision Date	March 11, 1992
Days to Decision	89 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF