The following data is part of a premarket notification filed by Innovision A/s with the FDA for Cardiopulmonary Exercise Testing Option To Innocor.
| Device ID | K071911 |
| 510k Number | K071911 |
| Device Name: | CARDIOPULMONARY EXERCISE TESTING OPTION TO INNOCOR |
| Classification | Computer, Diagnostic, Programmable |
| Applicant | INNOVISION A/S 1025 EVERETT ROAD SUITE 100 Lake Forest, IL 60045 |
| Contact | Richard O Wood |
| Correspondent | Richard O Wood INNOVISION A/S 1025 EVERETT ROAD SUITE 100 Lake Forest, IL 60045 |
| Product Code | DQK |
| CFR Regulation Number | 870.1425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-11 |
| Decision Date | 2007-09-07 |
| Summary: | summary |