Convex and Linear Array Transducers
FDA 510(k) K923269 · Aloka Co., Ltd.
510(k) numberK923269
Submission
- Device name
- Convex and Linear Array Transducers
- Applicant
- Aloka Co., Ltd.
Wallingford, CT, US - Received
- July 6, 1992
- Decision date
- December 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Convex and Linear Array Transducers cleared by the FDA?
Convex and Linear Array Transducers (K923269) received a 510(k) decision of Substantially Equivalent on December 3, 1992, 150 days after the submission was received.
What is the product code of K923269?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.