The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova 4 Na/k/c1/tco2/li Analyzer.
| Device ID | K915176 |
| 510k Number | K915176 |
| Device Name: | NOVA 4 NA/K/C1/TCO2/LI 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 |
| CFR Regulation Number | 862.1665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-15 |
| Decision Date | 1992-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385480157428 | K915176 | 000 |
| 00385480156479 | K915176 | 000 |
| 00385480141871 | K915176 | 000 |
| 00385480140829 | K915176 | 000 |
| 00385480136839 | K915176 | 000 |
| 00385480068567 | K915176 | 000 |