The following data is part of a premarket notification filed by Koven Technology, Inc. with the FDA for Echo Sounder Ex-101ex 8 Mhz.
| Device ID | K031931 |
| 510k Number | K031931 |
| Device Name: | ECHO SOUNDER EX-101EX 8 MHZ |
| Classification | Flowmeter, Blood, Cardiovascular |
| 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 | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-23 |
| Decision Date | 2004-02-13 |
| Summary: | summary |