The following data is part of a premarket notification filed by Bourns Medical Systems, Inc. with the FDA for Ventilator Model Bv-300 Infant.
| Device ID | K790199 |
| 510k Number | K790199 |
| Device Name: | VENTILATOR MODEL BV-300 INFANT |
| 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 | 1979-01-26 |
| Decision Date | 1979-04-13 |