510(k) K000031
K000031 is an FDA 510(k) premarket notification submitted by Prime Pacific Health Innovations Corporation for the device "AQUANET, MODEL EC 2000". The FDA issued a decision of Substantially Equivalent on September 10, 2001. The device falls under product code KPL (Colonic Irrigation System), a Class II device regulated under 21 CFR 876.5220. Prime Pacific Health Innovations Corporation has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 10, 2001
- Date Received
- January 5, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Colonic Irrigation System
- Device Class
- Class II
- Regulation Number
- 876.5220
- Review Panel
- GU
- Submission Type