The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Abl800 Flex.
| Device ID | K041874 |
| 510k Number | K041874 |
| Device Name: | ABL800 FLEX |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Contact | Lene M Marnaes |
| Correspondent | Lene M Marnaes RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CIG |
| Subsequent Product Code | GHS |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | KHP |
| Subsequent Product Code | KQI |
| Subsequent Product Code | MQM |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-12 |
| Decision Date | 2004-10-08 |
| Summary: | summary |