K802829 is an FDA 510(k) clearance for the SCANLAN VASCU-STATT. This device is classified as a Protector, Skin Pressure (Class I - General Controls, product code FMP).
Submitted by Scanlan Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on January 15, 1981, 66 days after receiving the submission on November 10, 1980.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6450.
| 510(k) Number | K802829 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 10, 1980 |
| Decision Date | January 15, 1981 |
| Days to Decision | 66 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 |