K822650 is an FDA 510(k) clearance for the SUPER DONUT. This device is classified as a Bedding, Disposable, Medical (Class I - General Controls, product code KME).
Submitted by Alimed, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 30, 1982, 28 days after receiving the submission on September 2, 1982.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6060.
| 510(k) Number | K822650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1982 |
| Decision Date | September 30, 1982 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | KME — Bedding, Disposable, Medical |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6060 |