Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-A
FDA 510(k) K953530 · Biosound, Inc.
510(k) numberK953530
Submission
- Device name
- Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-A
- Applicant
- Biosound, Inc.
Indianapolis, IN, US - Received
- July 27, 1995
- Decision date
- April 8, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K953430 | Ultrasound Probe Biopsy AccessoriesITX · Traditional | 10/24/1995SE |
Questions and answers
When was Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-A cleared by the FDA?
Diagnostic Ultrasound Tranducers P10A, P12A, PT10A, PA11-A (K953530) received a 510(k) decision of Substantially Equivalent on April 8, 1996, 256 days after the submission was received.
What is the product code of K953530?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.