The following data is part of a premarket notification filed by Sd Biosensor with the FDA for Sd Gluconavii Mentor Bt Blood Glucose Monitoring System, Sd Gluconavii Mentor Bt Multi Blood Glucose Monitoring System.
| Device ID | K153201 |
| 510k Number | K153201 |
| Device Name: | SD GlucoNavii Mentor BT Blood Glucose Monitoring System, SD GlucoNavii Mentor BT Multi Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | SD BIOSENSOR C-4th & 5th, 16, Deogyeong-daero, 1556beon-gil, Yeongtong-gu Suwon-si, KR 443-813 |
| Contact | Yeon Park |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-04 |
| Decision Date | 2016-06-24 |
| Summary: | summary |