The following data is part of a premarket notification filed by Phasein Ab with the FDA for Isa Co2, Isa Ax+, Isa Or+.
| Device ID | K103604 |
| 510k Number | K103604 |
| Device Name: | ISA CO2, ISA AX+, ISA OR+ |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | PHASEIN AB 4213 WINNEQUAH DR. Madison, WI 53716 |
| Contact | David Weissburg |
| Correspondent | David Weissburg PHASEIN AB 4213 WINNEQUAH DR. Madison, WI 53716 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-09 |
| Decision Date | 2011-04-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350046131866 | K103604 | 000 |
| 17350046131627 | K103604 | 000 |
| 17350046131634 | K103604 | 000 |
| 17350046131641 | K103604 | 000 |
| 17350046131658 | K103604 | 000 |
| 17350046131665 | K103604 | 000 |
| 07350046131781 | K103604 | 000 |
| 07350046131798 | K103604 | 000 |
| 07350046131804 | K103604 | 000 |
| 07350046131811 | K103604 | 000 |
| 07350046131828 | K103604 | 000 |
| 07350046131835 | K103604 | 000 |
| 07350046131842 | K103604 | 000 |
| 07350046131859 | K103604 | 000 |
| 17350046131610 | K103604 | 000 |