The following data is part of a premarket notification filed by Bourns Medical Systems, Inc. with the FDA for Newbourns Infant Ventilator.
| Device ID | K802051 |
| 510k Number | K802051 |
| Device Name: | NEWBOURNS INFANT VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | BOURNS MEDICAL SYSTEMS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-08-25 |
| Decision Date | 1980-10-03 |