510(k) K190208
K190208 is an FDA 510(k) premarket notification submitted by Diversatek Healthcare for the device "Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe". The FDA issued a decision of Substantially Equivalent on October 3, 2019. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Diversatek Healthcare has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 3, 2019
- Date Received
- February 4, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Gastrointestinal Motility (Electrical)
- Device Class
- Class II
- Regulation Number
- 876.1725
- Review Panel
- GU
- Submission Type