The following data is part of a premarket notification filed by Sonometrics Systems, Inc. with the FDA for Orbiograph.
| Device ID | K781543 |
| 510k Number | K781543 |
| Device Name: | ORBIOGRAPH |
| Classification | Preamplifier, Ac-powered, Ophthalmic |
| Applicant | SONOMETRICS SYSTEMS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HLT |
| CFR Regulation Number | 886.1640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-09-08 |
| Decision Date | 1978-10-24 |