The following data is part of a premarket notification filed by Ohmeda Medical with the FDA for Ohmeda 5500 Airway Pressure Monitor.
| Device ID | K864536 |
| 510k Number | K864536 |
| Device Name: | OHMEDA 5500 AIRWAY PRESSURE MONITOR |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | OHMEDA MEDICAL 355 INVERNESS DR.SOUTH Englewood, CO 80112 -5810 |
| Contact | William W Belew |
| Correspondent | William W Belew OHMEDA MEDICAL 355 INVERNESS DR.SOUTH Englewood, CO 80112 -5810 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-17 |
| Decision Date | 1987-01-12 |