K841395 is an FDA 510(k) clearance for the SHOWER TROLLEY. This device is classified as a Lift, Patient, Non-ac-powered (Class I - General Controls, product code FSA).
Submitted by Setma, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 7, 1984, 34 days after receiving the submission on April 3, 1984.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5510.
| 510(k) Number | K841395 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1984 |
| Decision Date | May 07, 1984 |
| Days to Decision | 34 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FSA — Lift, Patient, Non-ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5510 |