The following data is part of a premarket notification filed by Zeiss Humphrey System with the FDA for Digital Ophthalmic Ultrasound Biomicroscope.
| Device ID | K923211 |
| 510k Number | K923211 |
| Device Name: | DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | ZEISS HUMPHREY SYSTEM 2992 ALVARADO ST. P.O. BOX 5400 San Leandro, CA 94577 |
| Contact | Berry Dodd |
| Correspondent | Berry Dodd ZEISS HUMPHREY SYSTEM 2992 ALVARADO ST. P.O. BOX 5400 San Leandro, CA 94577 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-01 |
| Decision Date | 1993-11-08 |