FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WOODLYN CLASSIC REFRACTOR, PHOROPTOR
K Number: K874900
·
Decision Dec 23, 1987
Classifications
1
FEI Numbers
61
Registration Numbers
62
Same Product Code
2
Applicant Total
19
Review Days
22
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Basic Information
- Device Name
- WOODLYN CLASSIC REFRACTOR, PHOROPTOR
- K Number
- K874900
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1770
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Woodlyn, Inc.
- Date Received
- December 1, 1987
- Decision Date
- December 23, 1987
- Product Code
- HKN
- 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 |
|---|---|---|---|
| HKN | Refractor, Manual, Non-Powered, Including Phoropter | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HKN), ordered by most recent decision date.
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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 |
| K890992 | WOODLYN OPHTHALMIC PROJECTOR | May 17, 1989 | 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 |