The following data is part of a premarket notification filed by Infopia Co., Ltd. with the FDA for Ble Smart Blood Glucose Monitoring System, Ble Smart Professional Blood Glucose Monitoring System.
| Device ID | K160365 |
| 510k Number | K160365 |
| Device Name: | BLE Smart Blood Glucose Monitoring System, BLE Smart Professional Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | Infopia Co., Ltd. 132, Anyangcheondong-ro, Dongan-gu Anyang, KR 14040 |
| Contact | Na Yun Kim |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 800 ROOSEVELT STE 417 Irvine, CA 92620 |
| Product Code | NBW |
| Subsequent Product Code | JJX |
| Subsequent Product Code | LFR |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-09 |
| Decision Date | 2016-09-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00852668007187 | K160365 | 000 |
| 00852668007071 | K160365 | 000 |
| 00852668007064 | K160365 | 000 |
| 00852668007019 | K160365 | 000 |
| 00850081003960 | K160365 | 000 |