The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport Ventilator Model E150.
| Device ID | K883809 |
| 510k Number | K883809 |
| Device Name: | NEWPORT VENTILATOR MODEL E150 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. N Costa Mesa, CA 92627 |
| Contact | Cyndy Miller |
| Correspondent | Cyndy Miller NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. N Costa Mesa, CA 92627 |
| Product Code | CBK |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-08 |
| Decision Date | 1989-06-23 |