The following data is part of a premarket notification filed by Cavitron Corp. with the FDA for Model Pm-20(n)(r)co2 Patient Monitor/ala.
| Device ID | K800869 |
| 510k Number | K800869 |
| Device Name: | MODEL PM-20(N)(R)CO2 PATIENT MONITOR/ALA |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | CAVITRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-17 |
| Decision Date | 1980-05-28 |