SSD-650 Linear, Convex Sector, Ultrasound Scanning
FDA 510(k) K871400 · Ge Medical Systems Information Technologies
510(k) numberK871400
Submission
- Device name
- SSD-650 Linear, Convex Sector, Ultrasound Scanning
- Applicant
- Ge Medical Systems Information Technologies
Wallingford, CT, US - Received
- April 8, 1987
- Decision date
- July 24, 1987
- 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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Questions and answers
When was SSD-650 Linear, Convex Sector, Ultrasound Scanning cleared by the FDA?
SSD-650 Linear, Convex Sector, Ultrasound Scanning (K871400) received a 510(k) decision of Substantially Equivalent on July 24, 1987, 107 days after the submission was received.
What is the product code of K871400?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.