Model SSH-140A Ultrasound Imaging System
FDA 510(k) K894632 · Toshiba America Medical Systems, In.C
510(k) numberK894632
Submission
- Device name
- Model SSH-140A Ultrasound Imaging System
- Applicant
- Toshiba America Medical Systems, In.C
Tustin, CA, US - Received
- July 24, 1989
- Decision date
- October 19, 1989
- 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 Model SSH-140A Ultrasound Imaging System cleared by the FDA?
Model SSH-140A Ultrasound Imaging System (K894632) received a 510(k) decision of Substantially Equivalent on October 19, 1989, 87 days after the submission was received.
What is the product code of K894632?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.