The following data is part of a premarket notification filed by Zeiss Humphrey System with the FDA for Ophthalmic A/b Scan System, Model 835 -- Modified.
| Device ID | K923348 |
| 510k Number | K923348 |
| Device Name: | OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED |
| Classification | Transducer, Ultrasonic, Diagnostic |
| 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 | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-28 |
| Decision Date | 1992-12-10 |