FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WOODLYN OPHTHALMIC PROJECTOR
K Number: K890992
·
Decision May 17, 1989
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
8
Applicant Total
19
Review Days
79
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
- WOODLYN OPHTHALMIC PROJECTOR
- K Number
- K890992
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1680
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Woodlyn, Inc.
- Date Received
- February 27, 1989
- Decision Date
- May 17, 1989
- Product Code
- HOS
- 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 |
|---|---|---|---|
| HOS | Projector, Ophthalmic | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HOS), ordered by most recent decision date.
WIRELESS CHART PROJECTOR,HCP-W 721
FDA 510(k)
FDA Class 1
·Ophthalmic
MARCO CP-600 AUTO CHART PROJECTOR/CP-1 CHART PROJE
FDA 510(k)
FDA Class 1
·Ophthalmic
BURTON PROJECTOR HEAD - MODEL 6000-H
FDA 510(k)
FDA Class 1
·Ophthalmic
OPHTHALMIC PROJECTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
BAUSCH & LOMB ACCU-CHART 3 ACUITY PROJECTOR
FDA 510(k)
FDA Class 1
·Ophthalmic
MILLER/NADLER GLARE TESTER
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Woodlyn, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931303 | WOODLYN OPERATION MICROSCOPE | Jun 25, 1993 | Substantially Equivalent |
| K920861 | WOODLYN CLASSIC LENSMETER | Jul 30, 1992 | Substantially Equivalent |
| K900478 | WOODLYN FULL APERTURE TRIAL LENS SET | Feb 21, 1990 | Substantially Equivalent |
| K900476 | WOODLYN SLIT LAMP MODEL HR-1 | Feb 21, 1990 | Substantially Equivalent |
| K900477 | WOODLYN CLASSIC SLIT LAMP MODEL SMM | Feb 21, 1990 | Substantially Equivalent |
| K874900 | WOODLYN CLASSIC REFRACTOR, PHOROPTOR | Dec 23, 1987 | Substantially Equivalent |
| K843812 | WOODLYN CLASSIC CATARACT ACUITY TEST | Dec 11, 1984 | Substantially Equivalent |
| K841761 | WOODLYN CLASSIC SLIT LAMP HSSL-CL | Aug 7, 1984 | Substantially Equivalent |
| K841765 | WOODLYN STANDARD SLIT LAMP HSSL-ST | Aug 7, 1984 | Substantially Equivalent |
| K841767 | WOODLYN CLASSIC KERATOMETER | Aug 7, 1984 | Substantially Equivalent |