The following data is part of a premarket notification filed by Mercury Medical with the FDA for Mercury Medical Statco2 End Tidal Co2 Detector, Model 10-55370.
| Device ID | K021576 |
| 510k Number | K021576 |
| Device Name: | MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MERCURY MEDICAL 11300 49TH ST. NORTH Clearwater, FL 33762 -4800 |
| Contact | Ronald Rupenski |
| Correspondent | Ronald Rupenski 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 | 2002-05-14 |
| Decision Date | 2002-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10641043553701 | K021576 | 000 |