510(k) K133260
K133260 is an FDA 510(k) premarket notification submitted by Tianjin Empecs Medical Device Co., Ltd. for the device "MEDISIGN BLOOD GLUCSE MONITORING SYSTEM, MEDISIGN MULTI BLOOD GLUCOSE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 27, 2014. The device falls under product code NBW (System, Test, Blood Glucose, Over The Counter), a Class II device regulated under 21 CFR 862.1345. Tianjin Empecs Medical Device Co., Ltd. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 27, 2014
- Date Received
- Oct 23, 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)