The following data is part of a premarket notification filed by Mercury Medical with the FDA for Neo-stat Co2.
| Device ID | K083056 |
| 510k Number | K083056 |
| Device Name: | NEO-STAT CO2 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MERCURY MEDICAL 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden MERCURY MEDICAL 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-10-14 |
| Decision Date | 2009-02-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30641043553736 | K083056 | 000 |