The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport Aura Ventilator.
| Device ID | K121891 |
| 510k Number | K121891 |
| Device Name: | NEWPORT AURA VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NEWPORT MEDICAL INSTRUMENTS, INC. 1620 SUNFLOWER AVE. Costa Mesa, CA 92626 |
| Contact | Tom Colonna |
| Correspondent | Tom Colonna NEWPORT MEDICAL INSTRUMENTS, INC. 1620 SUNFLOWER AVE. Costa Mesa, CA 92626 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-29 |
| Decision Date | 2012-11-09 |
| Summary: | summary |