FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WOODLYN CLASSIC EXAM. CHAIR
K Number: K842045
·
Decision Jun 19, 1984
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
15
Applicant Total
19
Review Days
29
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 CLASSIC EXAM. CHAIR
- K Number
- K842045
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1140
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Woodlyn, Inc.
- Date Received
- May 21, 1984
- Decision Date
- June 19, 1984
- Product Code
- HME
- 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 |
|---|---|---|---|
| HME | Chair, Ophthalmic, Ac-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HME), ordered by most recent decision date.
MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
BREATH-EASY, MODIFICATION
FDA 510(k)
FDA Class 1
·Ophthalmic
RELIANCE(R) 6200 EXAMINATION CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
STORZ ENT/OPHTHALMIC MAXI CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
MAC 150E OPTHALMIC CHAIR
FDA 510(k)
FDA Class 1
·Ophthalmic
MODEL 6500 OPTHALMIC CHAIR
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 |
| 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 |