The following data is part of a premarket notification filed by Bio Medicus, Inc. with the FDA for (pbs) Portable Bypass System, Model 1000.
| Device ID | K901253 |
| 510k Number | K901253 |
| Device Name: | (PBS) PORTABLE BYPASS SYSTEM, MODEL 1000 |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Contact | Thomas K Johnsen |
| Correspondent | Thomas K Johnsen BIO MEDICUS, INC. 9600 W. 76 ST. Eden Prairie, MN 55344 |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-16 |
| Decision Date | 1990-09-05 |