The following data is part of a premarket notification filed by Biotest Medical Corporation with the FDA for Wowgohealth Blood Glucose Monitoring System.
| Device ID | K171785 |
| 510k Number | K171785 |
| Device Name: | WowGoHealth Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Biotest Medical Corporation No. 3-2, Chien-kuo Rd., TEPZ Tantzu Dist. Taichung, TW 42760 |
| Contact | Fred Lee |
| Correspondent | Fred Lee Biotest Medical Corporation No. 3-2, Chien-kuo Rd. TEPZ Tantzu Dist. Taichung, TW 42760 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-15 |
| Decision Date | 2017-09-15 |
| Summary: | summary |