The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for Bio Medicus Bio Pump Model Bp-80.
Device ID | K852698 |
510k Number | K852698 |
Device Name: | BIO MEDICUS BIO PUMP MODEL BP-80 |
Classification | Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
Applicant | BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
Contact | John R Dalpee |
Correspondent | John R Dalpee BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
Product Code | KFM |
CFR Regulation Number | 870.4360 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-26 |
Decision Date | 1985-09-30 |