The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Na/k/cl/li Module.
| Device ID | K922943 |
| 510k Number | K922943 |
| Device Name: | NOVA NA/K/CL/LI MODULE |
| 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 | 1992-06-18 |
| Decision Date | 1992-10-13 |