K935247 is an FDA 510(k) clearance for the JEDMED COMPACT ENDOSCOPIC BEAMSPLITTER. This device is classified as a Attachment, Teaching, For Endoscope (Class I - General Controls, product code FEA).
Submitted by Jedmed Instrument Co. (St.Louis, US). The FDA issued a Cleared decision on February 18, 1994, 109 days after receiving the submission on November 1, 1993.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1500.
| 510(k) Number | K935247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 01, 1993 |
| Decision Date | February 18, 1994 |
| Days to Decision | 109 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Statement |
| Product Code | FEA — Attachment, Teaching, For Endoscope |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 876.1500 |