Clearance Summary
STUDIO ON THE CLOUD DATA MANAGEMENT SOFTWARE received FDA 510(k) clearance under submission number DEN140016, sponsored by Dexcom, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2014-08-19.
- Submission: DEN140016
- Applicant / Sponsor: Dexcom, Inc.
- Clearance pathway: Direct
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2120
- Decision date: 2014-08-19
Classification & Regulation
This clearance is catalogued under FDA product code PHV and 21 CFR 862.2120, within the Clinical Chemistry review panel as a Class I device.