IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE— 510(k) K915577

Name: FDA 510(k) clearance K915577
Creator: U.S. Food and Drug Administration
Published: 1992-03-11

Substantially Equivalent

Impra, Inc.

FDA 510(k) clearance K915577 for IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE, Substantially Equivalent on 1992-03-11. Applicant: Impra, Inc.. Device class: 2.

Clearance details

Applicant: Impra, Inc.
Product code: Code CAR
Device class: Class 2
Regulation: 21 CFR 880.2460
Advisory panel: General Hospital
Date received: 1991-12-13
Decision date: 1992-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tempe, AZ, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.