SSD-870 Cardio Vascular Phased Array Sector Scann.
FDA 510(k) K880217 · Ge Medical Systems Information Technologies
510(k) numberK880217
Submission
- Device name
- SSD-870 Cardio Vascular Phased Array Sector Scann.
- Applicant
- Ge Medical Systems Information Technologies
Wallingford, CT, US - Received
- January 20, 1988
- Decision date
- April 25, 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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| K904978 | Software Program Used W/Prism ProductsDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
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Questions and answers
When was SSD-870 Cardio Vascular Phased Array Sector Scann. cleared by the FDA?
SSD-870 Cardio Vascular Phased Array Sector Scann. (K880217) received a 510(k) decision of Substantially Equivalent on April 25, 1988, 96 days after the submission was received.
What is the product code of K880217?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.