K772062 is an FDA 510(k) clearance for the NEONATAL 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 November 15, 1977, 13 days after receiving the submission on November 2, 1977.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5150.
| 510(k) Number | K772062 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 02, 1977 |
| Decision Date | November 15, 1977 |
| Days to Decision | 13 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 |