K820584 is an FDA 510(k) clearance for the DECUBICARE PADS & ACCESSORIES. This device is classified as a Protector, Skin Pressure (Class I - General Controls, product code FMP).
Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 25, 1982, 21 days after receiving the submission on March 4, 1982.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6450.
| 510(k) Number | K820584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 04, 1982 |
| Decision Date | March 25, 1982 |
| Days to Decision | 21 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | FMP — Protector, Skin Pressure |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.6450 |