The following data is part of a premarket notification filed by Icor Ab with the FDA for Icor Cmu Q Plus.
| Device ID | K895935 |
| 510k Number | K895935 |
| Device Name: | ICOR CMU Q PLUS |
| Classification | Computer, Oxygen-uptake |
| Applicant | ICOR AB ULVSUNDAVAGEN 178 B Bromma, SE 161 30 |
| Contact | Gedeon, Phd |
| Correspondent | Gedeon, Phd ICOR AB ULVSUNDAVAGEN 178 B Bromma, SE 161 30 |
| Product Code | BZL |
| CFR Regulation Number | 868.1730 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-11 |
| Decision Date | 1990-01-04 |