510(k) K151236
K151236 is an FDA 510(k) premarket notification submitted by Medtronic Minimed, Inc. for the device "MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)". The FDA issued a decision of Substantially Equivalent on May 19, 2015. The device falls under product code PJT (Continuous Glucose Monitor Secondary Display), a Class II device regulated under 21 CFR 862.1350. Medtronic Minimed, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2015
- Date Received
- May 11, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Continuous Glucose Monitor Secondary Display
- Device Class
- Class II
- Regulation Number
- 862.1350
- Review Panel
- CH
- Submission Type
The purpose of the continuous glucose monitor secondary display is to notify another person, the follower, of the patient's continuous glucose monitoring system sensor glucose information in real time. The secondary display is intended for providing secondary notification of a continuous glucose monitoring system and does not replace primary real time continuous glucose monitoring or standard home blood glucose monitoring