The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport E500 Wave Ventilator.
| Device ID | K061094 |
| 510k Number | K061094 |
| Device Name: | NEWPORT E500 WAVE VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NEWPORT MEDICAL INSTRUMENTS, INC. 1620 SUNFLOWER AVE. Costa Mesa, CA 92626 |
| Contact | Richard Waters |
| Correspondent | Richard Waters NEWPORT MEDICAL INSTRUMENTS, INC. 1620 SUNFLOWER AVE. Costa Mesa, CA 92626 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-19 |
| Decision Date | 2006-07-28 |
| Summary: | summary |