The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport Wave Ventilator Model E200.
| Device ID | K901785 |
| 510k Number | K901785 |
| Device Name: | NEWPORT WAVE VENTILATOR MODEL E200 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NEWPORT MEDICAL INSTRUMENTS, INC. P.O. BOX 2600 Newport Beach, CA 92658 |
| Contact | Miller, Rrt |
| Correspondent | Miller, Rrt NEWPORT MEDICAL INSTRUMENTS, INC. P.O. BOX 2600 Newport Beach, CA 92658 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-04-18 |
| Decision Date | 1990-08-10 |