FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MENTOR B-VAT(TM) II VIDEO TESTER
K Number: K875112
·
Decision Mar 8, 1988
Classifications
1
FEI Numbers
106
Registration Numbers
107
Same Product Code
31
Applicant Total
18
Review Days
84
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MENTOR B-VAT(TM) II VIDEO TESTER
- K Number
- K875112
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Mentor O & O, Inc.
- Date Received
- December 15, 1987
- Decision Date
- March 8, 1988
- Product Code
- HOX
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HOX | Chart, Visual Acuity | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HOX), ordered by most recent decision date.
CENTRAL VISION ANALYZER MODEL 1000
FDA 510(k)
FDA Class 1
·Ophthalmic
HEINE LAMBDA 100
FDA 510(k)
FDA Class 1
·Ophthalmic
OCCU-TECH VISION TEST
FDA 510(k)
FDA Class 1
·Ophthalmic
PL 20/20 INFANT VISION TESTER
FDA 510(k)
FDA Class 1
·Ophthalmic
VISUAL CONTRAST SENSITI., POTENTIAL ACUITY&GLARE
FDA 510(k)
FDA Class 1
·Ophthalmic
PG CONSEN CONTRAST SENSITIVITY TESTING PROGRAM
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Mentor O & O, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K955245 | MENTOR MERIDIAN PHACOEMULSIFICATION SYSTEM | Feb 12, 1996 | Substantially Equivalent |
| K934320 | MENTOR WET-FIELD HEMOSTATIC ERASER BIPOLAR INSTRUMENT, 20 GAUGE WITH EXTRUSION ASPIRATION | Feb 16, 1994 | Substantially Equivalent |
| K912904 | MENTOR ODYSSEY PHACOEMULSIFICATION SYSTEM | Jun 11, 1992 | Substantially Equivalent |
| K915340 | MENTOR HORIZON LOW VISION MAGNIFIER | Mar 30, 1992 | Substantially Equivalent |
| K910637 | MENTOR(R) SUR-E-TROL(R) | May 13, 1991 | Substantially Equivalent |
| K911160 | MENTOR(R) WET-FIELD(R) II AC COAGULATOR, 22-1305 | May 2, 1991 | Substantially Equivalent |
| K903878 | MENTOR(R) DURASTAT(TM) AUTOCLAV BIPOLAR HEMOSTAT | Nov 5, 1990 | Substantially Equivalent |
| K895010 | MENTOR SPECTACLE BINOCULAR INDIRECT OPHTHALMOSCOPE | Sep 11, 1989 | Substantially Equivalent |
| K890622 | SURG-E-TROL SYSTEM I AND SYSTEM II | May 4, 1989 | Substantially Equivalent |
| K890595 | MENTOR ANTERIOR SEGMENT VITRECTOR | Apr 17, 1989 | Substantially Equivalent |