Model Ust-Ssd 880L1-5 Tranesophageal Phased Array
FDA 510(k) K861710 · Johnson & Johnson Professionals, Inc.
510(k) numberK861710
Submission
- Device name
- Model Ust-Ssd 880L1-5 Tranesophageal Phased Array
- Applicant
- Johnson & Johnson Professionals, Inc.
Ramsey, NJ, US - Received
- May 5, 1986
- Decision date
- July 9, 1986
- 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 Model Ust-Ssd 880L1-5 Tranesophageal Phased Array cleared by the FDA?
Model Ust-Ssd 880L1-5 Tranesophageal Phased Array (K861710) received a 510(k) decision of Substantially Equivalent on July 9, 1986, 65 days after the submission was received.
What is the product code of K861710?
The FDA product code is DXK – Echocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2330.