Interson Usb Ultrasound Probe System
FDA 510(k) K070907 · Regulatory Management Services
510(k) numberK070907
Submission
- Device name
- Interson Usb Ultrasound Probe System
- Applicant
- Regulatory Management Services
San Leandro, CA, US - Received
- April 2, 2007
- Decision date
- April 17, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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Questions and answers
When was Interson Usb Ultrasound Probe System cleared by the FDA?
Interson Usb Ultrasound Probe System (K070907) received a 510(k) decision of Substantially Equivalent on April 17, 2007, 15 days after the submission was received.
What is the product code of K070907?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.