The following data is part of a premarket notification filed by Icor Ab with the FDA for Fhb, Fhb-t With Or Without Flextube Hfh, Hfh-t, Afa, Afh-t With Or Without Flexrtube.
| Device ID | K952823 |
| 510k Number | K952823 |
| Device Name: | FHB, FHB-T WITH OR WITHOUT FLEXTUBE HFH, HFH-T, AFA, AFH-T WITH OR WITHOUT FLEXRTUBE |
| 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 | 1995-06-20 |
| Decision Date | 1995-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 29555342305757 | K952823 | 000 |
| 29555342304262 | K952823 | 000 |
| 49555342304150 | K952823 | 000 |
| 29555342304149 | K952823 | 000 |
| 29555342304088 | K952823 | 000 |
| 29555342304002 | K952823 | 000 |
| 49555342303917 | K952823 | 000 |