Video Urodynamics Sys 1906B-Y & 1906C-Y
FDA 510(k) K843198 · Life-Tech Intl., Inc.
510(k) numberK843198
Submission
- Device name
- Video Urodynamics Sys 1906B-Y & 1906C-Y
- Applicant
- Life-Tech Intl., Inc.
Mchenry, IL, US - Received
- August 14, 1984
- Decision date
- October 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 Video Urodynamics Sys 1906B-Y & 1906C-Y cleared by the FDA?
Video Urodynamics Sys 1906B-Y & 1906C-Y (K843198) received a 510(k) decision of Substantially Equivalent on October 4, 1984, 51 days after the submission was received.
What is the product code of K843198?
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.