Meridian Ultrasound Imaging System
FDA 510(k) K853240 · Johnson & Johnson Professionals, Inc.
510(k) numberK853240
Submission
- Device name
- Meridian Ultrasound Imaging System
- Applicant
- Johnson & Johnson Professionals, Inc.
Ramsey, NJ, US - Received
- August 1, 1985
- Decision date
- February 21, 1986
- 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 Meridian Ultrasound Imaging System cleared by the FDA?
Meridian Ultrasound Imaging System (K853240) received a 510(k) decision of Substantially Equivalent on February 21, 1986, 204 days after the submission was received.
What is the product code of K853240?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.