K771824 is an FDA 510(k) clearance for the MEDPRO FLOTATION SYSTEM. This device is classified as a Mattress, Flotation Therapy, Non-powered (Class I - General Controls, product code IKY).
Submitted by Medpro, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 19, 1977, 22 days after receiving the submission on September 27, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5150.
| 510(k) Number | K771824 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 27, 1977 |
| Decision Date | October 19, 1977 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | IKY — Mattress, Flotation Therapy, Non-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5150 |