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 |