The following data is part of a premarket notification filed by Icor Ab with the FDA for Breath-easy.
| Device ID | K881308 |
| 510k Number | K881308 |
| Device Name: | BREATH-EASY |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | ICOR AB ULVSUNDAVAGEN 178 B Bromma, SE 161 30 |
| Contact | Carl Hamilton |
| Correspondent | Carl Hamilton 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 | 1988-03-28 |
| Decision Date | 1988-05-17 |