The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Abl837 Flex Analyzer.
| Device ID | K100777 |
| 510k Number | K100777 |
| Device Name: | ABL837 FLEX ANALYZER |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Contact | Rowena Jansson |
| Correspondent | Rowena Jansson RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Product Code | CHL |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-18 |
| Decision Date | 2010-12-10 |
| Summary: | summary |