Clearance Summary
my Patch sl received FDA 510(k) clearance under submission number K163535, sponsored by Dms-Service, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2017-02-22.
- Submission: K163535
- Applicant / Sponsor: Dms-Service, LLC
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2800
- Decision date: 2017-02-22
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.