The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport E360 Ventilator.
| Device ID | K101803 |
| 510k Number | K101803 |
| Device Name: | NEWPORT E360 VENTILATOR |
| Classification | Ventilator, Continuous, Facility Use |
| Applicant | NEWPORT MEDICAL INSTRUMENTS, INC. 1620 SUNFLOWER AVE. Costa Mesa, CA 92626 |
| Contact | Tom Colonna |
| Correspondent | Tom Colonna 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 | 2010-06-28 |
| Decision Date | 2010-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521510791 | K101803 | 000 |
| 10884521208957 | K101803 | 000 |
| 10884521541009 | K101803 | 000 |
| 10884521541382 | K101803 | 000 |
| 10884521510838 | K101803 | 000 |
| 10884521510807 | K101803 | 000 |
| 10884521510586 | K101803 | 000 |
| 10884521541078 | K101803 | 000 |
| 10884521510852 | K101803 | 000 |
| 10884521510647 | K101803 | 000 |
| 10884521511293 | K101803 | 000 |
| 10884521511286 | K101803 | 000 |
| 10884521511774 | K101803 | 000 |
| 10884521511279 | K101803 | 000 |
| 10884521510869 | K101803 | 000 |
| 10884521208971 | K101803 | 000 |
| 10884521510821 | K101803 | 000 |
| 10884521212183 | K101803 | 000 |
| 10884521510845 | K101803 | 000 |
| 10884521510760 | K101803 | 000 |
| 10884521541399 | K101803 | 000 |
| 10884521541146 | K101803 | 000 |
| 10884521511903 | K101803 | 000 |
| 10884521510784 | K101803 | 000 |
| 10884521510623 | K101803 | 000 |
| 10884521510593 | K101803 | 000 |
| 10884521511385 | K101803 | 000 |