The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Stat Profile Phox Plus Analyzer.
| Device ID | K000895 |
| 510k Number | K000895 |
| Device Name: | STAT PROFILE PHOX PLUS ANALYZER |
| Classification | Electrode, Ion Specific, Sodium |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul W Macdonald |
| Correspondent | Paul W Macdonald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | JGS |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | JFP |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-20 |
| Decision Date | 2000-04-17 |