RT5000 W/Quanti. Spec. Doppler, CW Dopp. Modifica.
FDA 510(k) K871555 · General Electric Co.
510(k) numberK871555
Submission
- Device name
- RT5000 W/Quanti. Spec. Doppler, CW Dopp. Modifica.
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- April 22, 1987
- Decision date
- March 2, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXK – Echocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2330
- Specialty
- Cardiovascular
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| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
| K072075 | Modification to GE Logiq A3IYN · Special | 08/29/2007SE |
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Questions and answers
When was RT5000 W/Quanti. Spec. Doppler, CW Dopp. Modifica. cleared by the FDA?
RT5000 W/Quanti. Spec. Doppler, CW Dopp. Modifica. (K871555) received a 510(k) decision of Substantially Equivalent on March 2, 1988, 315 days after the submission was received.
What is the product code of K871555?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.