The following data is part of a premarket notification filed by Biomagnetic Technologies, Inc. with the FDA for Ibt Model Svi.
| Device ID | K921821 |
| 510k Number | K921821 |
| Device Name: | IBT MODEL SVI |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BIOMAGNETIC TECHNOLOGIES, INC. 9021 45TH AVE N. Newhope, MN 55428 |
| Contact | Michael J Boyle |
| Correspondent | Michael J Boyle BIOMAGNETIC TECHNOLOGIES, INC. 9021 45TH AVE N. Newhope, MN 55428 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-16 |
| Decision Date | 1992-11-02 |