510(k) K170241
K170241 is an FDA 510(k) premarket notification submitted by All Medicus Co., Ltd. for the device "GlucoDr.S Blood Glucose Monitoring System, GlucoDr.S BLE Blood Glucose Monitoring System, GlucoDr.S NFC Blood Glucose Monitoring System". The FDA issued a decision of Substantially Equivalent on Oct 13, 2017. 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
- Oct 13, 2017
- Date Received
- Jan 26, 2017
- 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)