SSD-725 Ultrasound Sector Scanner
FDA 510(k) K870607 · Ge Medical Systems Information Technologies
510(k) numberK870607
Submission
- Device name
- SSD-725 Ultrasound Sector Scanner
- Applicant
- Ge Medical Systems Information Technologies
Wallingford, CT, US - Received
- February 11, 1987
- Decision date
- August 10, 1987
- 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 SSD-725 Ultrasound Sector Scanner cleared by the FDA?
SSD-725 Ultrasound Sector Scanner (K870607) received a 510(k) decision of Substantially Equivalent on August 10, 1987, 180 days after the submission was received.
What is the product code of K870607?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.