Nobles-Lai Imaging System
FDA 510(k) K920026 · Nobles-Lai Engineering, Inc.
510(k) numberK920026
Submission
- Device name
- Nobles-Lai Imaging System
- Applicant
- Nobles-Lai Engineering, Inc.
Costa Mesa, CA, US - Received
- January 3, 1992
- Decision date
- July 28, 1992
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 Nobles-Lai Imaging System cleared by the FDA?
Nobles-Lai Imaging System (K920026) received a 510(k) decision of Unknown on July 28, 1992, 207 days after the submission was received.
What is the product code of K920026?
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.