The following data is part of a premarket notification filed by Icor Ab with the FDA for Afh, Afh Flex, Afh/t, Afh/t Flex, Af.
| Device ID | K941436 |
| 510k Number | K941436 |
| Device Name: | AFH, AFH FLEX, AFH/T, AFH/T FLEX, AF |
| 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 | 1994-03-24 |
| Decision Date | 1994-06-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 49555342304204 | K941436 | 000 |
| 49555342304020 | K941436 | 000 |
| 29555342304064 | K941436 | 000 |
| 29555342304057 | K941436 | 000 |