The following data is part of a premarket notification filed by Innomed Technologies with the FDA for Modification To Nasal-aire.
| Device ID | K022465 |
| 510k Number | K022465 |
| Device Name: | MODIFICATION TO NASAL-AIRE |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | INNOMED TECHNOLOGIES 506 GARDEN STREET Greensburg, PA 15601 |
| Contact | Marge Walls-walker |
| Correspondent | Marge Walls-walker INNOMED TECHNOLOGIES 506 GARDEN STREET Greensburg, PA 15601 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-26 |
| Decision Date | 2003-03-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10607411942263 | K022465 | 000 |
| 10607411940795 | K022465 | 000 |
| 10607411942065 | K022465 | 000 |
| 10607411942072 | K022465 | 000 |
| 10607411942089 | K022465 | 000 |
| 10607411942096 | K022465 | 000 |
| 10607411942102 | K022465 | 000 |
| 10607411942119 | K022465 | 000 |
| 10607411942201 | K022465 | 000 |
| 10607411942218 | K022465 | 000 |
| 10607411942225 | K022465 | 000 |
| 10607411942232 | K022465 | 000 |
| 10607411942249 | K022465 | 000 |
| 10607411942256 | K022465 | 000 |
| 10607411940788 | K022465 | 000 |