The following data is part of a premarket notification filed by Phasein Ab with the FDA for Irma C02 Model 200101; Irma Ax 200601.
| Device ID | K123043 |
| 510k Number | K123043 |
| Device Name: | IRMA C02 MODEL 200101; IRMA AX 200601 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | PHASEIN AB 404 WILLIAMSON ST. SUITE 402 Madison, WI 53703 |
| Contact | David Weissburg |
| Correspondent | David Weissburg PHASEIN AB 404 WILLIAMSON ST. SUITE 402 Madison, WI 53703 |
| Product Code | CCK |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | NHO |
| Subsequent Product Code | NHP |
| Subsequent Product Code | NHQ |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-28 |
| Decision Date | 2012-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350046131903 | K123043 | 000 |
| 07350046132122 | K123043 | 000 |
| 17350046131597 | K123043 | 000 |
| 17350046131603 | K123043 | 000 |
| 07350046131675 | K123043 | 000 |
| 07350046131682 | K123043 | 000 |
| 07350046131699 | K123043 | 000 |
| 07350046131705 | K123043 | 000 |
| 07350046131712 | K123043 | 000 |
| 07350046131729 | K123043 | 000 |
| 07350046131736 | K123043 | 000 |
| 07350046132030 | K123043 | 000 |