The following data is part of a premarket notification filed by Radiometer Medical A/s with the FDA for Abl-700 Series, Model Abl 7xx (various Models).
| Device ID | K002290 |
| 510k Number | K002290 |
| Device Name: | ABL-700 SERIES, MODEL ABL 7XX (VARIOUS MODELS) |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | RADIOMETER MEDICAL A/S AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Contact | Kirsten Rono |
| Correspondent | Kirsten Rono RADIOMETER MEDICAL A/S 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 | GKF |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | KHP |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-27 |
| Decision Date | 2000-09-13 |