The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Model Irc Passport Nebulizer.
| Device ID | K914251 |
| 510k Number | K914251 |
| Device Name: | MODEL IRC PASSPORT NEBULIZER |
| Classification | Theophylline Control Materials |
| Applicant | INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll INVACARE CORP. 899 CLEVELAND ST. P.O. BOX 4028 Elyria, OH 44036 |
| Product Code | LAW |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-23 |
| Decision Date | 1992-01-24 |