The following data is part of a premarket notification filed by Icor Ab with the FDA for Icor Agent Monitor.
| Device ID | K883532 |
| 510k Number | K883532 |
| Device Name: | ICOR AGENT MONITOR |
| Classification | Analyzer, Gas, Enflurane, Gaseous-phase (anesthetic Concentration) |
| 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 | CBQ |
| CFR Regulation Number | 868.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-18 |
| Decision Date | 1988-11-04 |