The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Stat Profile Prime Es Comp Plus Analyzer System.
| Device ID | K191365 |
| 510k Number | K191365 |
| Device Name: | Stat Profile Prime ES Comp Plus Analyzer System |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454 |
| Contact | Cesidio Tempesta |
| Correspondent | Cesidio Tempesta Nova Biomedical Corporation 200 Prospect St. Waltham, MA 02454 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JJE |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-22 |
| Decision Date | 2019-07-19 |