The following data is part of a premarket notification filed by Icor Ab with the FDA for Type 1 & 2 (humidair I & Ii).
| Device ID | K953507 |
| 510k Number | K953507 |
| Device Name: | TYPE 1 & 2 (HUMIDAIR I & II) |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | ICOR AB ULVSUNDAVAGEN 178 B Bromma, SE 161 30 |
| Contact | Andras Gedeon |
| Correspondent | Andras Gedeon ICOR AB ULVSUNDAVAGEN 178 B Bromma, SE 161 30 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-26 |
| Decision Date | 1995-09-07 |