FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WOODLYN APPLANATION TONOMETER
K Number: K841762
·
Decision Aug 2, 1984
Classifications
1
FEI Numbers
36
Registration Numbers
37
Same Product Code
57
Applicant Total
19
Review Days
97
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Basic Information
- Device Name
- WOODLYN APPLANATION TONOMETER
- K Number
- K841762
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1930
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Woodlyn, Inc.
- Date Received
- April 27, 1984
- Decision Date
- August 2, 1984
- Product Code
- HKX
- 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 |
|---|---|---|---|
| HKX | Tonometer, Ac-Powered | FDA class 2 | Ophthalmic |
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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 |
| 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 |