Myopach Ultrasonic Pachometer
FDA 510(k) K844112 · Myocure, Inc.
510(k) numberK844112
Submission
- Device name
- Myopach Ultrasonic Pachometer
- Applicant
- Myocure, Inc.
Los Angeles, CA, US - Received
- October 23, 1984
- Decision date
- January 16, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Myopach Ultrasonic Pachometer cleared by the FDA?
Myopach Ultrasonic Pachometer (K844112) received a 510(k) decision of Substantially Equivalent on January 16, 1986, 450 days after the submission was received.
What is the product code of K844112?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.