The following data is part of a premarket notification filed by Invacare Corp. with the FDA for Model Irc 1001 Aerosol Compressor.
| Device ID | K992643 |
| 510k Number | K992643 |
| Device Name: | MODEL IRC 1001 AEROSOL COMPRESSOR |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | INVACARE CORP. ONE INVACARE WAY P.O. BOX 4028 Elyria, OH 44036 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll INVACARE CORP. ONE INVACARE WAY 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 | 1999-08-06 |
| Decision Date | 1999-10-27 |
| Summary: | summary |