The following data is part of a premarket notification filed by Bio-med Devices, Inc. with the FDA for Ic-2a Mri Adult/pediatric Ventilator.
| Device ID | K896380 |
| 510k Number | K896380 |
| Device Name: | IC-2A MRI ADULT/PEDIATRIC VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BIO-MED DEVICES, INC. 8 BISHOP LN. Madison, CT 06443 |
| Contact | Dean J Bennett |
| Correspondent | Dean J Bennett BIO-MED DEVICES, INC. 8 BISHOP LN. Madison, CT 06443 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1990-02-12 |