Gynesonics EC6 Transducer
FDA 510(k) K061153 · Gynesonics, Inc.
510(k) numberK061153
Submission
- Device name
- Gynesonics EC6 Transducer
- Applicant
- Gynesonics, Inc.
Redwood City, CA, US - Received
- April 26, 2006
- Decision date
- October 27, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Gynesonics EC6 Transducer cleared by the FDA?
Gynesonics EC6 Transducer (K061153) received a 510(k) decision of Substantially Equivalent on October 27, 2006, 184 days after the submission was received.
What is the product code of K061153?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.