The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Cpu-1 Intensive Care Ventilator.
| Device ID | K871398 |
| 510k Number | K871398 |
| Device Name: | CPU-1 INTENSIVE CARE VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Contact | Alberto F Profumo |
| Correspondent | Alberto F Profumo OHMEDA MEDICAL 9065 GUILFORD RD. Columbia, MD 21046 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-07 |
| Decision Date | 1987-05-07 |