K864846 is an FDA 510(k) clearance for the RADIOGRAPHIC - LEG SECTION. This device is classified as a Table, Cystometric, Non-electric And Accessories (Class I - General Controls, product code KQS).
Submitted by American Sterilizer Co. (Erie, US). The FDA issued a Cleared decision on December 24, 1986, 14 days after receiving the submission on December 10, 1986.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.4890.
| 510(k) Number | K864846 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 10, 1986 |
| Decision Date | December 24, 1986 |
| Days to Decision | 14 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KQS — Table, Cystometric, Non-electric And Accessories |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.4890 |