5.0 MHZ Array Intravaginal Transducer
FDA 510(k) K891309 · Advanced Technology Laboratories, Inc.
510(k) numberK891309
Submission
- Device name
- 5.0 MHZ Array Intravaginal Transducer
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- March 10, 1989
- Decision date
- May 16, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was 5.0 MHZ Array Intravaginal Transducer cleared by the FDA?
5.0 MHZ Array Intravaginal Transducer (K891309) received a 510(k) decision of Substantially Equivalent on May 16, 1989, 67 days after the submission was received.
What is the product code of K891309?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.