Zeiss Superlux High-Intensity Light Sources
FDA 510(k) K936198 · Carl Zeiss, Inc.
510(k) numberK936198
Submission
- Device name
- Zeiss Superlux High-Intensity Light Sources
- Applicant
- Carl Zeiss, Inc.
Thornwood, NY, US - Received
- December 29, 1993
- Decision date
- April 6, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GCT – Light Source, Endoscope, Xenon Arc
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| K013880 | Daylite Xenon Light SourcesGCT · Traditional | Designs For Vision, Inc. | 12/07/2001SE |
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Questions and answers
When was Zeiss Superlux High-Intensity Light Sources cleared by the FDA?
Zeiss Superlux High-Intensity Light Sources (K936198) received a 510(k) decision of Substantially Equivalent on April 6, 1994, 98 days after the submission was received.
What is the product code of K936198?
The FDA product code is GCT – Light Source, Endoscope, Xenon Arc, a Class II (moderate risk) device regulated under 21 CFR 876.1500.