The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for E100m Ventilator (e100m).
| Device ID | K972833 |
| 510k Number | K972833 |
| Device Name: | E100M VENTILATOR (E100M) |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. M Costa Mesa, CA 92627 |
| Contact | Karon Morell |
| Correspondent | Karon Morell NEWPORT MEDICAL INSTRUMENTS, INC. 760 WEST 16TH ST., BLDG. M 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 | 1997-07-30 |
| Decision Date | 1999-09-23 |