The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Abl835 Flex Analyzer With Pleural Ph.
| Device ID | K110416 |
| 510k Number | K110416 |
| Device Name: | ABL835 FLEX ANALYZER WITH PLEURAL PH |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | RADIOMETER MEDICAL APS AAKANDEVEJ 21 Broenshoejy, DK Dk-2700 |
| Contact | Soren Bogestrand |
| Correspondent | Soren Bogestrand RADIOMETER MEDICAL APS AAKANDEVEJ 21 Broenshoejy, DK Dk-2700 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-03-24 |
| Summary: | summary |