The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Model Irc 1199 Scout Nebulizer.
| Device ID | K973468 |
| 510k Number | K973468 |
| Device Name: | MODEL IRC 1199 SCOUT NEBULIZER |
| Classification | Nebulizer (direct Patient Interface) |
| 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 | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-12 |
| Decision Date | 1997-12-08 |
| Summary: | summary |