Impraflo Postoperative Autotransfusion Device

FDA 510(k) K915577 · Impra, Inc.

Substantially Equivalent

510(k) numberK915577

Submission

Device name
Impraflo Postoperative Autotransfusion Device
Applicant
Impra, Inc.
Tempe, AZ, US
Received
December 13, 1991
Decision date
March 11, 1992
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CAR – Monitor, Spinal-Fluid Pressure, Electrically Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 880.2460
Specialty
General Hospital

Other 510(k)s with product code CAR

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K920740Episensor PlusCAR · Traditional Industrias Palex C/O Dma Med-Chem Corp.03/07/1994SE
K926066Bion Mumps-G Antibody Test SystemCAR · Traditional Bion Ent., Ltd.06/15/1993SE

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Questions and answers

When was Impraflo Postoperative Autotransfusion Device cleared by the FDA?

Impraflo Postoperative Autotransfusion Device (K915577) received a 510(k) decision of Substantially Equivalent on March 11, 1992, 89 days after the submission was received.

What is the product code of K915577?

The FDA product code is CAR – Monitor, Spinal-Fluid Pressure, Electrically Powered, a Class II (moderate risk) device regulated under 21 CFR 880.2460.