The following data is part of a premarket notification filed by Icor Ab with the FDA for Breath-easy, Modification.
| Device ID | K914416 |
| 510k Number | K914416 |
| Device Name: | BREATH-EASY, MODIFICATION |
| Classification | Chair, Ophthalmic, Ac-powered |
| 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 | HME |
| CFR Regulation Number | 886.1140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-25 |
| Decision Date | 1992-06-23 |