The following data is part of a premarket notification filed by All Medicus Co., Ltd. with the FDA for Glucodr.s Blood Glucose Monitoring System, Glucodr.s Ble Blood Glucose Monitoring System, Glucodr.s Nfc Blood Glucose Monitoring System.
| Device ID | K170241 |
| 510k Number | K170241 |
| Device Name: | GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | All Medicus Co., Ltd. No. 7102-7107, 7402, 7403, 7406, 140, Beolmal-ro, Dongan-gu Anyang-si, KP 14057 |
| Contact | Hong-joo Park |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt STE 417 Irvine, CA 92620 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-26 |
| Decision Date | 2017-10-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806128351589 | K170241 | 000 |
| 08806128351565 | K170241 | 000 |
| 08806128351541 | K170241 | 000 |
| 08806128351503 | K170241 | 000 |