The following data is part of a premarket notification filed by Impra, Inc. with the FDA for Impraflo Postoperative Autotransfusion Device.
| Device ID | K915577 |
| 510k Number | K915577 |
| Device Name: | IMPRAFLO POSTOPERATIVE AUTOTRANSFUSION DEVICE |
| Classification | Monitor, Spinal-fluid Pressure, Electrically Powered |
| Applicant | IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Contact | Rich Kaufman |
| Correspondent | Rich Kaufman IMPRA, INC. 1625 WEST 3RD ST. P.O. BOX 1740 Tempe, AZ 85281 |
| Product Code | CAR |
| CFR Regulation Number | 880.2460 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-13 |
| Decision Date | 1992-03-11 |