FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE
K Number: K923211
·
Decision Nov 8, 1993
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
9
Review Days
495
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Basic Information
- Device Name
- DIGITAL OPHTHALMIC ULTRASOUND BIOMICROSCOPE
- K Number
- K923211
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zeiss Humphrey System
- Date Received
- July 1, 1992
- Decision Date
- November 8, 1993
- Product Code
- IYO
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Zeiss Humphrey System
| K Number | Device Name | ||
|---|---|---|---|
| K942439 | ZEISS OPMILAS 144 SURGICAL LASERS | Jul 1, 1994 | Substantially Equivalent |
| K923348 | OPHTHALMIC A/B SCAN SYSTEM, MODEL 835 -- MODIFIED | Dec 10, 1992 | Substantially Equivalent |
| K852639 | HUMPHREY FIELD ANALYZER MODEL 630 | Sep 18, 1985 | Substantially Equivalent |
| K852638 | HUMPHREY IMAGE ANALYZER MODEL 110 | Aug 12, 1985 | Substantially Equivalent |
| K821940 | THE HUMPHREY FIELD ANALYZER MODEL 610 | Jul 28, 1982 | Substantially Equivalent |
| K802029 | OBJECTIVE REFRACTOR | Nov 12, 1980 | Substantially Equivalent |
| K781994 | AUTOKERATOMETER, INSTRUMENT | Feb 12, 1979 | Substantially Equivalent |
| K782096 | INSTRUMENTS, OVERREFRACTION SYSTEM | Jan 26, 1979 | Substantially Equivalent |