The following data is part of a premarket notification filed by Aquaciser, Inc. with the FDA for Aquaciser Ii.
| Device ID | K925193 |
| 510k Number | K925193 |
| Device Name: | AQUACISER II |
| Classification | Bath, Hydro-massage |
| Applicant | AQUACISER, INC. 201 GORE CREEK RD. Vail, CO 81657 |
| Contact | Thomas H Hopkins |
| Correspondent | Thomas H Hopkins AQUACISER, INC. 201 GORE CREEK RD. Vail, CO 81657 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-15 |
| Decision Date | 1994-08-26 |