Sonoline CF
FDA 510(k) K875272 · Siemens Medical Laboratories, Inc.
510(k) numberK875272
Submission
- Device name
- Sonoline CF
- Applicant
- Siemens Medical Laboratories, Inc.
Pleasanton, CA, US - Received
- December 24, 1987
- Decision date
- February 18, 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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| K904976 | Cine'View - Stress Echo & Image ReviewDXK · Traditional | Prism Imaging, Inc. | 02/25/1991SE |
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| K862339 | Mevatron KD-2IYE · Traditional | 10/29/1986SE |
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| K852907 | Siemens Mevatron MeLHN · Traditional | 09/19/1985SE |
| K812032 | Mevatron 67EIYE · Traditional | 08/18/1981SE |
| K791967 | Mevatron 74X Medical Linear AcceleratorIYE · Traditional | 11/16/1979SE |
| K790747 | Mevatron 74IYE · Traditional | 05/04/1979SE |
Questions and answers
When was Sonoline CF cleared by the FDA?
Sonoline CF (K875272) received a 510(k) decision of Substantially Equivalent on February 18, 1988, 56 days after the submission was received.
What is the product code of K875272?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.