The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova 16 Analyzer (modification Point Of Care Usage).
| Device ID | K963005 |
| 510k Number | K963005 |
| Device Name: | NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE) |
| Classification | Ph Rate Measurement, Carbon-dioxide |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul W Mac Donald |
| Correspondent | Paul W Mac Donald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | JFL |
| Subsequent Product Code | CGL |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | GKF |
| CFR Regulation Number | 862.1160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-02 |
| Decision Date | 1996-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385480539859 | K963005 | 000 |
| 00385480173599 | K963005 | 000 |
| 00385480172899 | K963005 | 000 |
| 00385480170932 | K963005 | 000 |
| 00385480170925 | K963005 | 000 |
| 10385480164839 | K963005 | 000 |
| 00385480158190 | K963005 | 000 |
| 00385480142533 | K963005 | 000 |
| 00385480141826 | K963005 | 000 |
| 00385480139861 | K963005 | 000 |
| 00385480131773 | K963005 | 000 |
| 00385480131421 | K963005 | 000 |
| 00385480127042 | K963005 | 000 |
| 00385480112727 | K963005 | 000 |
| 00385480095839 | K963005 | 000 |
| 00385480081610 | K963005 | 000 |
| 00385480068574 | K963005 | 000 |
| 00385480001014 | K963005 | 000 |
| 00385480173605 | K963005 | 000 |
| 00385480173643 | K963005 | 000 |
| 10385480282410 | K963005 | 000 |
| 10385480215883 | K963005 | 000 |
| 00385480186551 | K963005 | 000 |
| 00385480186544 | K963005 | 000 |
| 00385480183420 | K963005 | 000 |
| 00385480178792 | K963005 | 000 |
| 10385480177556 | K963005 | 000 |
| 10385480176122 | K963005 | 000 |
| 00385480175180 | K963005 | 000 |
| 00385480175159 | K963005 | 000 |
| 00385480175142 | K963005 | 000 |
| 00385480175128 | K963005 | 000 |
| 00385480175111 | K963005 | 000 |
| 00385480175104 | K963005 | 000 |
| 00385480175098 | K963005 | 000 |
| 00385480174527 | K963005 | 000 |
| 00385480174367 | K963005 | 000 |
| 00385480000994 | K963005 | 000 |