The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport Ventilator Model E-100.
| Device ID | K860438 |
| 510k Number | K860438 |
| Device Name: | NEWPORT VENTILATOR MODEL E-100 |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NEWPORT MEDICAL INSTRUMENTS, INC. P.O. BOX 2600 Newport Beach, CA 92658 |
| Contact | Doug Domurat |
| Correspondent | Doug Domurat 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 | 1986-02-04 |
| Decision Date | 1986-05-06 |