The following data is part of a premarket notification filed by Optical Micro Systems, Inc. with the FDA for Machemer/tano Rotating.
| Device ID | K833820 |
| 510k Number | K833820 |
| Device Name: | MACHEMER/TANO ROTATING |
| Classification | Table, Instrument, Powered, Ophthalmic |
| Applicant | OPTICAL MICRO SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRJ |
| CFR Regulation Number | 886.4855 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-11-02 |
| Decision Date | 1984-01-04 |