The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Echo Sounder, Es-102ex.
| Device ID | K023143 |
| 510k Number | K023143 |
| Device Name: | ECHO SOUNDER, ES-102EX |
| Classification | Monitor, Ultrasonic, Fetal |
| Applicant | KOVEN TECHNOLOGY, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 -3404 |
| Contact | J. Harvey Knauss |
| Correspondent | J. Harvey Knauss KOVEN TECHNOLOGY, INC. 11874 SOUTH EVELYN CIRCLE Houston, TX 77071 -3404 |
| Product Code | KNG |
| CFR Regulation Number | 884.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-20 |
| Decision Date | 2002-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00894912002463 | K023143 | 000 |
| 00894912002432 | K023143 | 000 |
| 00894912002326 | K023143 | 000 |