K854263 is an FDA 510(k) clearance for the SETMA FHT, MODEL ST 8130. This device is classified as a Bath, Hydro-massage (Class II - Special Controls, product code ILJ).
Submitted by Setma, Inc. (Whitehouse, US). The FDA issued a Cleared decision on November 13, 1985, 21 days after receiving the submission on October 23, 1985.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5100.
| 510(k) Number | K854263 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1985 |
| Decision Date | November 13, 1985 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILJ — Bath, Hydro-massage |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5100 |