The following data is part of a premarket notification filed by Gynesonics, Inc. with the FDA for Gynesonics Ec6 Transducer.
| Device ID | K061153 |
| 510k Number | K061153 |
| Device Name: | GYNESONICS EC6 TRANSDUCER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | GYNESONICS, INC. 604 FIFTH AVE. SUITE D Redwood City, CA 94063 |
| Contact | Jessica Grossman, Md |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-04-26 |
| Decision Date | 2006-10-27 |
| Summary: | summary |