K031504 is an FDA 510(k) clearance for the ECHO SOUNDER, SINGLE-HANDED, MODEL ES-101EX. This device is classified as a Monitor, Ultrasonic, Fetal (Class II - Special Controls, product code KNG).
Submitted by Koven Technology, Inc. (Houston, US). The FDA issued a Cleared decision on July 18, 2003, 65 days after receiving the submission on May 14, 2003.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K031504 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2003 |
| Decision Date | July 18, 2003 |
| Days to Decision | 65 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KNG - Monitor, Ultrasonic, Fetal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.2660 |