The following data is part of a premarket notification filed by Apex Bio Technology Corp with the FDA for Autosure Voice 3 Plus Blood Glucose Monitoring System.
| Device ID | K120649 |
| 510k Number | K120649 |
| Device Name: | AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | APEX BIO TECHNOLOGY CORP NO. 7, LI-HSIN ROAD V HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Contact | Lisa Liu |
| Correspondent | Lisa Liu APEX BIO TECHNOLOGY CORP NO. 7, LI-HSIN ROAD V HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-02 |
| Decision Date | 2012-07-06 |
| Summary: | summary |