510(k) K131190
K131190 is an FDA 510(k) premarket notification submitted by Dms-Service, LLC for the device "MYPATCH". The FDA issued a decision of Substantially Equivalent on Oct 29, 2013. 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
- Oct 29, 2013
- Date Received
- Apr 26, 2013
- 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)