The following data is part of a premarket notification filed by Osang Healthcare Co., Ltd. with the FDA for Oh'care Lite Smart Blood Glucose Monitoring System.
| Device ID | K182286 |
| 510k Number | K182286 |
| Device Name: | Oh'Care Lite Smart Blood Glucose Monitoring System |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | OSANG Healthcare Co., Ltd. 132, Anyangcheondong-Ro, Dongan-Gu Anyang, KR 14040 |
| Contact | Jin Ho An |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 690 Roosevelt Irvine, CA 92620 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-23 |
| Decision Date | 2018-09-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809115906557 | K182286 | 000 |
| 08809115906540 | K182286 | 000 |
| 08809115906533 | K182286 | 000 |
| 08809115906526 | K182286 | 000 |
| 08809115906519 | K182286 | 000 |
| 08809115905376 | K182286 | 000 |
| 08809115905352 | K182286 | 000 |