The following data is part of a premarket notification filed by Mercury Medical with the FDA for Statco2meter, Model 10-55372.
| Device ID | K031814 |
| 510k Number | K031814 |
| Device Name: | STATCO2METER, MODEL 10-55372 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MERCURY MEDICAL 11300 49TH ST. NORTH Clearwater, FL 33762 -4800 |
| Contact | Wayne Glover |
| Correspondent | Wayne Glover MERCURY MEDICAL 11300 49TH ST. NORTH Clearwater, FL 33762 -4800 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-12 |
| Decision Date | 2003-08-14 |
| Summary: | summary |