The Tulip LCI-200 Illumination & Imaging System (Modification)
FDA 510(k) K954734 · The Tulip Mfg. Co.
510(k) numberK954734
Submission
- Device name
- The Tulip LCI-200 Illumination & Imaging System (Modification)
- Applicant
- The Tulip Mfg. Co.
Mesa, AZ, US - Received
- October 3, 1995
- Decision date
- November 14, 1995
- 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 The Tulip LCI-200 Illumination & Imaging System (Modification) cleared by the FDA?
The Tulip LCI-200 Illumination & Imaging System (Modification) (K954734) received a 510(k) decision of Substantially Equivalent on November 14, 1995, 42 days after the submission was received.
What is the product code of K954734?
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.