The following data is part of a premarket notification filed by Invacare Respiratory Corp. with the FDA for Model Dx Micro Computer Control.
| Device ID | K970094 |
| 510k Number | K970094 |
| Device Name: | MODEL DX MICRO COMPUTER CONTROL |
| Classification | Wheelchair, Powered |
| Applicant | INVACARE RESPIRATORY CORP. 899 CLEVELAND ST. Elyria, OH 44036 -2125 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll INVACARE RESPIRATORY CORP. 899 CLEVELAND ST. Elyria, OH 44036 -2125 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-01-10 |
| Decision Date | 1997-05-12 |
| Summary: | summary |