510(k) K163535
K163535 is an FDA 510(k) premarket notification submitted by Dms-Service, LLC for the device "my Patch sl". The FDA issued a decision of Substantially Equivalent on Feb 22, 2017. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Dms-Service, LLC has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 22, 2017
- Date Received
- Dec 16, 2016
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Recorder, Magnetic Tape, Medical
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type
- 510(k)