The following data is part of a premarket notification filed by Nova Biomedical Corp. with the FDA for Nova Max Plus Blood Glucose And B-ketone Monitor System, Nova Max Plus B-ketone Control Solutions, Nova Max Blood Glucos.
| Device ID | K091547 |
| 510k Number | K091547 |
| Device Name: | NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Contact | Paul Macdonald |
| Correspondent | Paul Macdonald NOVA BIOMEDICAL CORP. 200 PROSPECT ST. Waltham, MA 02454 -9141 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JIN |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-27 |
| Decision Date | 2010-01-15 |
| Summary: | summary |