The following data is part of a premarket notification filed by All Medicus Co., Ltd with the FDA for Linkdr 2.0 Diabetes Management Software.
| Device ID | K130657 |
| 510k Number | K130657 |
| Device Name: | LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | ALL MEDICUS CO., LTD 1515 E. KATELLA AVE. UNIT 2115 Anaheim, CA 92805 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung ALL MEDICUS CO., LTD 1515 E. KATELLA AVE. UNIT 2115 Anaheim, CA 92805 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-12 |
| Decision Date | 2013-07-15 |
| Summary: | summary |