510(k) K150910
K150910 is an FDA 510(k) premarket notification submitted by Roche Diabetes Care, Inc. for the device "ACCU-CHEK Connect Diabetes Management App". The FDA issued a decision of Substantially Equivalent on Jun 3, 2015. The device falls under product code NDC (Calculator, Drug Dose), a Class II device regulated under 21 CFR 868.1890. Roche Diabetes Care, Inc. has 12 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 3, 2015
- Date Received
- Apr 3, 2015
- Clearance Type
- Special
- 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
- 510(k)