The following data is part of a premarket notification filed by Innomed Technologies with the FDA for Nasal-air Critical Care.
| Device ID | K031896 |
| 510k Number | K031896 |
| Device Name: | NASAL-AIR CRITICAL CARE |
| Classification | Ventilator, Continuous, Non-life-supporting |
| Applicant | INNOMED TECHNOLOGIES 506 GARDEN STREET Greensburg, PA 15601 |
| Contact | Frank Pelc |
| Correspondent | Frank Pelc INNOMED TECHNOLOGIES 506 GARDEN STREET Greensburg, PA 15601 |
| Product Code | MNS |
| CFR Regulation Number | 868.5895 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-19 |
| Decision Date | 2004-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607411942389 | K031896 | 000 |
| 00607411942280 | K031896 | 000 |
| 10607411942294 | K031896 | 000 |
| 10607411942300 | K031896 | 000 |
| 10607411942317 | K031896 | 000 |
| 10607411942324 | K031896 | 000 |
| 10607411942331 | K031896 | 000 |
| 00607411942341 | K031896 | 000 |
| 10607411942355 | K031896 | 000 |
| 10607411942362 | K031896 | 000 |
| 10607411942379 | K031896 | 000 |
| 10607411942270 | K031896 | 000 |