K914921 is an FDA 510(k) clearance for the SCM-3 AND ACCESSORIES. This device is classified as a Mattress, Flotation Therapy, Non-powered (Class I - General Controls, product code IKY).
Submitted by Gaymar Industries, Inc. (Orchard Park, US). The FDA issued a Cleared decision on March 12, 1992, 129 days after receiving the submission on November 4, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5150.
| 510(k) Number | K914921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 1991 |
| Decision Date | March 12, 1992 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | IKY — Mattress, Flotation Therapy, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5150 |