510(k) K141929
K141929 is an FDA 510(k) premarket notification submitted by Roche Diagnostics Corporation for the device "ACCU-CHEK CONNECT DIABETES MANAGEMENT APP". The FDA issued a decision of Substantially Equivalent on March 16, 2015. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890. Roche Diagnostics Corporation has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 2015
- Date Received
- July 16, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calculator, Drug Dose
- Device Class
- Class II
- Regulation Number
- 868.1890
- Review Panel
- CH
- Submission Type