The following data is part of a premarket notification filed by Icor Ab with the FDA for Fhb, Fhb-t, Fhbflex, Fhbflex-t.
| Device ID | K925622 |
| 510k Number | K925622 |
| Device Name: | FHB, FHB-T, FHBFLEX, FHBFLEX-T |
| 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 | 1992-11-06 |
| Decision Date | 1993-05-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 29555342304255 | K925622 | 000 |
| 29555342304194 | K925622 | 000 |
| 29555342304125 | K925622 | 000 |
| 49555342303948 | K925622 | 000 |