Trans-Scan 3-D Transcranial Doppler
FDA 510(k) K874685 · Carolina Medical Electronics
510(k) numberK874685
Submission
- Device name
- Trans-Scan 3-D Transcranial Doppler
- Applicant
- Carolina Medical Electronics
King, NC, US - Received
- November 12, 1987
- Decision date
- April 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K810561 | Dopscan Model 1050DPW · Traditional | 04/10/1981SE |
| K801647 | Sonacolor 6100DXY · Traditional | 08/20/1980SE |
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Questions and answers
When was Trans-Scan 3-D Transcranial Doppler cleared by the FDA?
Trans-Scan 3-D Transcranial Doppler (K874685) received a 510(k) decision of Substantially Equivalent on April 25, 1988, 165 days after the submission was received.
What is the product code of K874685?
The FDA product code is IYO – System, Imaging, Pulsed Echo, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 892.1560.