The following data is part of a premarket notification filed by Newport Medical Instruments, Inc. with the FDA for Newport Ht70 Ventilator.
| Device ID | K111146 |
| 510k Number | K111146 |
| Device Name: | NEWPORT HT70 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-22 |
| Decision Date | 2011-12-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884521544062 | K111146 | 000 |
| 10884521542037 | K111146 | 000 |
| 10884521542075 | K111146 | 000 |
| 10884521543942 | K111146 | 000 |
| 10884521542204 | K111146 | 000 |
| 10884521542235 | K111146 | 000 |
| 10884521542242 | K111146 | 000 |
| 10884521544291 | K111146 | 000 |
| 10884521544307 | K111146 | 000 |
| 10884521544338 | K111146 | 000 |
| 10884521544376 | K111146 | 000 |
| 10884521544383 | K111146 | 000 |
| 10884521208995 | K111146 | 000 |
| 10884521774049 | K111146 | 000 |
| 10884521544444 | K111146 | 000 |
| 10884521208940 | K111146 | 000 |
| 10884521541948 | K111146 | 000 |
| 10884521542259 | K111146 | 000 |
| 20884521542034 | K111146 | 000 |