Scanheads-Access 10PV, Biostatic
FDA 510(k) K843620 · Advanced Technology Laboratories, Inc.
510(k) numberK843620
Submission
- Device name
- Scanheads-Access 10PV, Biostatic
- Applicant
- Advanced Technology Laboratories, Inc.
Bellevue, WA, US - Received
- September 14, 1984
- Decision date
- March 12, 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 Scanheads-Access 10PV, Biostatic cleared by the FDA?
Scanheads-Access 10PV, Biostatic (K843620) received a 510(k) decision of Substantially Equivalent on March 12, 1985, 179 days after the submission was received.
What is the product code of K843620?
The FDA product code is JOP – Transducer, Ultrasonic, a Class II (moderate risk) device regulated under 21 CFR 870.2880.