510(k) K130657
K130657 is an FDA 510(k) premarket notification submitted by All Medicus Co., Ltd. for the device "LINKDR 2.0 DIABETES MANAGEMENT SOFTWARE". The FDA issued a decision of Substantially Equivalent on Jul 15, 2013. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. All Medicus Co., Ltd. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 15, 2013
- Date Received
- Mar 12, 2013
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Test, Blood Glucose, Over The Counter
- Device Class
- Class II
- Regulation Number
- 862.1345
- Review Panel
- CH
- Submission Type
- 510(k)