Precision Optics Endoscope Adapter
FDA 510(k) K903459 · Precise Optics
510(k) numberK903459
Submission
- Device name
- Precision Optics Endoscope Adapter
- Applicant
- Precise Optics
Gardner, MA, US - Received
- August 1, 1990
- Decision date
- October 26, 1990
- 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 Precision Optics Endoscope Adapter cleared by the FDA?
Precision Optics Endoscope Adapter (K903459) received a 510(k) decision of Substantially Equivalent on October 26, 1990, 86 days after the submission was received.
What is the product code of K903459?
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.