The following data is part of a premarket notification filed by Nova Biomedical Corporation with the FDA for Nova Stat Profile Prime Ccs Analyzer System.
| Device ID | K131703 |
| 510k Number | K131703 |
| Device Name: | NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM |
| Classification | Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph |
| Applicant | NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham, MA 02454 |
| Contact | Paul W Mcdonald |
| Correspondent | Paul W Mcdonald NOVA BIOMEDICAL CORPORATION 200 Prospect St Waltham, MA 02454 |
| Product Code | CHL |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | GKF |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| Subsequent Product Code | JJS |
| CFR Regulation Number | 862.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-11 |
| Decision Date | 2014-03-25 |
| Summary: | summary |