K023143 is an FDA 510(k) clearance for the ECHO SOUNDER, ES-102EX. 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 December 19, 2002, 90 days after receiving the submission on September 20, 2002.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 884.2660.
| 510(k) Number | K023143 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2002 |
| Decision Date | December 19, 2002 |
| Days to Decision | 90 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 |