The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Zeiss Superlux High-intensity Light Sources.
| Device ID | K936198 |
| 510k Number | K936198 |
| Device Name: | ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES |
| Classification | Light Source, Endoscope, Xenon Arc |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Cynthia A Gifford, Rn |
| Correspondent | Cynthia A Gifford, Rn CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Product Code | GCT |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-29 |
| Decision Date | 1994-04-06 |