3.0 MHZ Phased Array Scanhead W/2.0 MHZ Sidearm CW
FDA 510(k) K871432 · Advanced Technology Laboratories, Inc.
510(k) numberK871432
Submission
- Device name
- 3.0 MHZ Phased Array Scanhead W/2.0 MHZ Sidearm CW
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- April 13, 1987
- Decision date
- August 7, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was 3.0 MHZ Phased Array Scanhead W/2.0 MHZ Sidearm CW cleared by the FDA?
3.0 MHZ Phased Array Scanhead W/2.0 MHZ Sidearm CW (K871432) received a 510(k) decision of Substantially Equivalent on August 7, 1987, 116 days after the submission was received.
What is the product code of K871432?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.