The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Abl90 Flex Series.
| Device ID | K092686 |
| 510k Number | K092686 |
| Device Name: | ABL90 FLEX SERIES |
| Classification | Electrode, Ion Specific, Potassium |
| Applicant | RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Contact | Lone Ronnemoes Pedersen |
| Correspondent | Lone Ronnemoes Pedersen RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CHL |
| Subsequent Product Code | GHS |
| Subsequent Product Code | GKR |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJY |
| Subsequent Product Code | KHP |
| Subsequent Product Code | KQI |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-02 |
| Decision Date | 2010-08-06 |
| Summary: | summary |