The following data is part of a premarket notification filed by Prime Pacific Health Innovations Corporation with the FDA for Aquanet, Model Ec 2000.
| Device ID | K000031 |
| 510k Number | K000031 |
| Device Name: | AQUANET, MODEL EC 2000 |
| Classification | Colonic Irrigation System |
| Applicant | PRIME PACIFIC HEALTH INNOVATIONS CORPORATION 145 RIVERSIDE DR. North Vancouver, CA V7h 1t6 |
| Contact | Othmar Vogel |
| Correspondent | Othmar Vogel PRIME PACIFIC HEALTH INNOVATIONS CORPORATION 145 RIVERSIDE DR. North Vancouver, CA V7h 1t6 |
| Product Code | KPL |
| CFR Regulation Number | 876.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-05 |
| Decision Date | 2001-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07540198000121 | K000031 | 000 |
| 07540198000114 | K000031 | 000 |
| 07540198000107 | K000031 | 000 |