The following data is part of a premarket notification filed by Radiometer Medical Aps with the FDA for Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3.
| Device ID | K130236 |
| 510k Number | K130236 |
| Device Name: | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 |
| Classification | Controls For Blood-gases, (assayed And Unassayed) |
| Applicant | RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Contact | Martin Gabler |
| Correspondent | Martin Gabler RADIOMETER MEDICAL APS AKANDEVEJ 21 Bronshoj, DK Dk-2700 |
| Product Code | JJS |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-30 |
| Decision Date | 2013-03-15 |
| Summary: | summary |