The following data is part of a premarket notification filed by Carl Zeiss, Inc. with the FDA for Indirect Ophthalmoscope.
| Device ID | K853891 |
| 510k Number | K853891 |
| Device Name: | INDIRECT OPHTHALMOSCOPE |
| Classification | Ophthalmoscope, Battery-powered |
| Applicant | CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Contact | Marie Pederson |
| Correspondent | Marie Pederson CARL ZEISS, INC. ONE ZEISS DR. Thornwood, NY 10594 |
| Product Code | HLJ |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-09-19 |
| Decision Date | 1985-10-04 |