The following data is part of a premarket notification filed by Spectramed, Inc. with the FDA for Spectramed Model Sp1455 Hemopro2 System.
| Device ID | K865101 |
| 510k Number | K865101 |
| Device Name: | SPECTRAMED MODEL SP1455 HEMOPRO2 SYSTEM |
| Classification | Computer, Diagnostic, Pre-programmed, Single-function |
| Applicant | SPECTRAMED, INC. 2530 PENNSYLVANIA AVENUE SOUTH St. Louis Park, MN 55426 |
| Contact | Freedman, Phd |
| Correspondent | Freedman, Phd SPECTRAMED, INC. 2530 PENNSYLVANIA AVENUE SOUTH St. Louis Park, MN 55426 |
| Product Code | DXG |
| CFR Regulation Number | 870.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-30 |
| Decision Date | 1987-04-20 |