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 |