The following data is part of a premarket notification filed by Phasein Ab with the FDA for Emma Analyzer (kpa & Mmhg); Emma Monitor (kpa & Mmhg).
| Device ID | K072813 |
| 510k Number | K072813 |
| Device Name: | EMMA ANALYZER (KPA & MMHG); EMMA MONITOR (KPA & MMHG) |
| 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 | 2007-10-01 |
| Decision Date | 2007-12-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17350046131566 | K072813 | 000 |