Clearance Summary
myPatch-s received FDA 510(k) clearance under submission number K160704, sponsored by Dms-Service, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2016-07-15.
- Submission: K160704
- Applicant / Sponsor: Dms-Service, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2016-07-15
Classification & Regulation
This clearance is catalogued under FDA product code DSH and 21 CFR 870.2800, within the Cardiovascular review panel as a Class II device.