Level 10 Hdi
FDA 510(k) K961459 · Advanced Technology Laboratories, Inc.
510(k) numberK961459
Submission
- Device name
- Level 10 Hdi
- Applicant
- Advanced Technology Laboratories, Inc.
Bothell, WA, US - Received
- April 16, 1996
- Decision date
- March 26, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Level 10 Hdi cleared by the FDA?
Level 10 Hdi (K961459) received a 510(k) decision of Substantially Equivalent on March 26, 1997, 344 days after the submission was received.
What is the product code of K961459?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.