The following data is part of a premarket notification filed by Apex Biotechnology Corp. with the FDA for Glucosure Voice Blood Glucose Monitoring System, Model As90011e1.
| Device ID | K073137 |
| 510k Number | K073137 |
| Device Name: | GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | APEX BIOTECHNOLOGY CORP. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Contact | Thomas Y.s. Sheen |
| Correspondent | Thomas Y.s. Sheen APEX BIOTECHNOLOGY CORP. NO. 7, LI-HSIN ROAD V, HSINCHU SCIENCE PARK Hsinchu, TW 30078 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-11-07 |
| Decision Date | 2008-04-01 |
| Summary: | summary |