Cardiac Sector Probe 3.5. MHZ
FDA 510(k) K850145 · Siemens Medical Solutions USA, Inc.
510(k) numberK850145
Submission
- Device name
- Cardiac Sector Probe 3.5. MHZ
- Applicant
- Siemens Medical Solutions USA, Inc.
Iselin, NJ, US - Received
- January 14, 1985
- Decision date
- April 10, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JOP – Transducer, Ultrasonic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2880
- Specialty
- Cardiovascular
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Questions and answers
When was Cardiac Sector Probe 3.5. MHZ cleared by the FDA?
Cardiac Sector Probe 3.5. MHZ (K850145) received a 510(k) decision of Substantially Equivalent on April 10, 1985, 86 days after the submission was received.
What is the product code of K850145?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.