The following data is part of a premarket notification filed by Phasein Ab with the FDA for Emma Analyzer (kpa) And (mmhg); Emma Monitor (kpa) And (mmhg).
| Device ID | K063167 |
| 510k Number | K063167 |
| Device Name: | EMMA ANALYZER (KPA) AND (MMHG); EMMA MONITOR (KPA) AND (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 | 2006-10-18 |
| Decision Date | 2007-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350046131774 | K063167 | 000 |
| 07350046131767 | K063167 | 000 |
| 07350046131750 | K063167 | 000 |
| 07350046131743 | K063167 | 000 |
| 17350046131559 | K063167 | 000 |
| 07350046131514 | K063167 | 000 |
| 07350046131507 | K063167 | 000 |
| 07350046131040 | K063167 | 000 |
| 07350046131033 | K063167 | 000 |