The following data is part of a premarket notification filed by Pharma System Ab with the FDA for Bact-trap Filter, Bact-trap Mini, Bact-trap Midi, Pharma Mini Hme/filter, Bact-hme Hme/filter And Bact-hme Midi Hme/filter.
| Device ID | K202459 |
| 510k Number | K202459 |
| Device Name: | Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter And Bact-HME Midi HME/Filter |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | Pharma System AB Rubanksgatan 9 Knivsta, SE 74171 |
| Contact | Viljar Salumaa |
| Correspondent | Scott Blood MEDIcept Inc. 200 Homer Ave Ashland, MA 01721 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-27 |
| Decision Date | 2021-09-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30734000672332 | K202459 | 000 |
| 30734000671564 | K202459 | 000 |
| 30734000671540 | K202459 | 000 |
| 30734000671441 | K202459 | 000 |
| 30734000671434 | K202459 | 000 |
| 30734000671267 | K202459 | 000 |
| 30734000671243 | K202459 | 000 |
| 30734000671182 | K202459 | 000 |
| 30734000671076 | K202459 | 000 |
| 30734000671588 | K202459 | 000 |
| 30734000671946 | K202459 | 000 |
| 30734000672325 | K202459 | 000 |
| 30734000672318 | K202459 | 000 |
| 30734000672202 | K202459 | 000 |
| 30734000672196 | K202459 | 000 |
| 30734000672189 | K202459 | 000 |
| 30734000671977 | K202459 | 000 |
| 30734000671960 | K202459 | 000 |
| 30734000671953 | K202459 | 000 |
| 30734000671007 | K202459 | 000 |