Olympus Switching Unit Model SU-1
FDA 510(k) K944081 · Olympus America, Inc.
510(k) numberK944081
Submission
- Device name
- Olympus Switching Unit Model SU-1
- Applicant
- Olympus America, Inc.
Lake Success, NY, US - Received
- August 22, 1994
- Decision date
- November 14, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FET – Endoscopic Video Imaging System/Component, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To allow for visualization of body cavities through an endoscope by projecting images to a monitor.
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Questions and answers
When was Olympus Switching Unit Model SU-1 cleared by the FDA?
Olympus Switching Unit Model SU-1 (K944081) received a 510(k) decision of Substantially Equivalent on November 14, 1994, 84 days after the submission was received.
What is the product code of K944081?
The FDA product code is FET – Endoscopic Video Imaging System/Component, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.