510(k) K013154
K013154 is an FDA 510(k) premarket notification submitted by Dentsleeve Pty., Ltd. for the device "MARK II/MARK III MANOMETRIC PERFUSION PUMP". The FDA issued a decision of Substantially Equivalent on October 19, 2001. The device falls under product code FFX (System, Gastrointestinal Motility (Electrical)), a Class II device regulated under 21 CFR 876.1725. Dentsleeve Pty., Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 19, 2001
- Date Received
- September 20, 2001
- Clearance Type
- Special
- 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