Genesis II Transcranial Probe
FDA 510(k) K883238 · Biosound, Inc.
510(k) numberK883238
Submission
- Device name
- Genesis II Transcranial Probe
- Applicant
- Biosound, Inc.
Indianapolis, IN, US - Received
- August 1, 1988
- Decision date
- August 24, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Genesis II Transcranial Probe cleared by the FDA?
Genesis II Transcranial Probe (K883238) received a 510(k) decision of Substantially Equivalent on August 24, 1988, 23 days after the submission was received.
What is the product code of K883238?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.