The following data is part of a premarket notification filed by Setma, Inc. with the FDA for Setma Vht.
| Device ID | K853163 |
| 510k Number | K853163 |
| Device Name: | SETMA VHT |
| Classification | Bath, Hydro-massage |
| Applicant | SETMA, INC. Whitehouse, NJ 08888 |
| Contact | Richard B Dardas |
| Correspondent | Richard B Dardas SETMA, INC. Whitehouse, NJ 08888 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-30 |
| Decision Date | 1985-11-05 |