The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova 8 Crt Analyzer.
| Device ID | K924547 |
| 510k Number | K924547 |
| Device Name: | NOVA 8 CRT 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 | 1992-09-09 |
| Decision Date | 1993-01-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385480539927 | K924547 | 000 |
| 00385480132947 | K924547 | 000 |
| 00385480150866 | K924547 | 000 |
| 00385480151962 | K924547 | 000 |
| 10385480152157 | K924547 | 000 |
| 00385480152631 | K924547 | 000 |
| 10385480152645 | K924547 | 000 |
| 10385480152652 | K924547 | 000 |
| 00385480231312 | K924547 | 000 |
| 10385480539910 | K924547 | 000 |
| 00385480131438 | K924547 | 000 |