The following data is part of a premarket notification filed by Bourns Medical Systems, Inc. with the FDA for Model Bp-200 Infant Pressure Ventilator.
| Device ID | K801697 |
| 510k Number | K801697 |
| Device Name: | MODEL BP-200 INFANT PRESSURE VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BOURNS MEDICAL SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-23 |
| Decision Date | 1980-08-07 |