510(k) K160704
K160704 is an FDA 510(k) premarket notification submitted by Dms-Service, LLC for the device "myPatch-s". The FDA issued a decision of Substantially Equivalent on Jul 15, 2016. 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
- Jul 15, 2016
- Date Received
- Mar 14, 2016
- Clearance Type
- Traditional
- 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)