Scanhead 2.25MHZ Added to Ultramark 4
FDA 510(k) K843130 · Advanced Technology Laboratories, Inc.
510(k) numberK843130
Submission
- Device name
- Scanhead 2.25MHZ Added to Ultramark 4
- Applicant
- Advanced Technology Laboratories, Inc.
Mchenry, IL, US - Received
- August 9, 1984
- Decision date
- December 6, 1984
- 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 Scanhead 2.25MHZ Added to Ultramark 4 cleared by the FDA?
Scanhead 2.25MHZ Added to Ultramark 4 (K843130) received a 510(k) decision of Substantially Equivalent on December 6, 1984, 119 days after the submission was received.
What is the product code of K843130?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.