Company ยท US
Zeiss Humphrey System
FDA 510(k) clearances and medical device recalls filed under this name, 1979 to 1994. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HPT | Perimeter, Automatic, Ac-Powered | 2 |
| GEX | Powered Laser Surgical Instrument | 1 |
| HKI | Camera, Ophthalmic, Ac-Powered | 1 |
| HKO | Refractometer, Ophthalmic | 1 |
| HLM | Instrument, Measuring, Lens, Ac-Powered | 1 |
| HLQ | Keratoscope, Ac-Powered | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 |
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 1, 1994 | K942439 | ZEISS OPMILAS 144 SURGICAL LASERS Zeiss Humphrey System | GEX |
| Nov 8, 1993 | K923211 | DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE Zeiss Humphrey System | IYO |
| Dec 10, 1992 | K923348 | OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED Zeiss Humphrey System | ITX |
| Sep 18, 1985 | K852639 | HUMPHREY FIELD ANALYZER MODEL 630 Zeiss Humphrey System | HPT |
| Aug 12, 1985 | K852638 | HUMPHREY IMAGE ANALYZER MODEL 110 Zeiss Humphrey System | HKI |
| Jul 28, 1982 | K821940 | THE HUMPHREY FIELD ANALYZER MODEL 610 Zeiss Humphrey System | HPT |
| Nov 12, 1980 | K802029 | OBJECTIVE REFRACTOR Zeiss Humphrey System | HKO |
| Feb 12, 1979 | K781994 | AUTOKERATOMETER, INSTRUMENT Zeiss Humphrey System | HLQ |
| Jan 26, 1979 | K782096 | INSTRUMENTS, OVERREFRACTION SYSTEM Zeiss Humphrey System | HLM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||