Olympus JF-UM3-7.5/-12 and CF-UM3-7.5/-12
FDA 510(k) K900880 · Olympus Corp.
510(k) numberK900880
Submission
- Device name
- Olympus JF-UM3-7.5/-12 and CF-UM3-7.5/-12
- Applicant
- Olympus Corp.
Lake Success, NY, US - Received
- February 26, 1990
- Decision date
- April 29, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Olympus JF-UM3-7.5/-12 and CF-UM3-7.5/-12 cleared by the FDA?
Olympus JF-UM3-7.5/-12 and CF-UM3-7.5/-12 (K900880) received a 510(k) decision of Substantially Equivalent on April 29, 1991, 427 days after the submission was received.
What is the product code of K900880?
The FDA product code is ITX – Transducer, Ultrasonic, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 892.1570.