The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova 5 Na/k/c1 Alalyzer.
| Device ID | K915177 |
| 510k Number | K915177 |
| Device Name: | NOVA 5 NA/K/C1 ALALYZER |
| Classification | Electrode, Ion Specific, Potassium |
| 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 | CEM |
| CFR Regulation Number | 862.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-15 |
| Decision Date | 1992-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385480539897 | K915177 | 000 |
| 00385480156486 | K915177 | 000 |
| 10385480141564 | K915177 | 000 |