FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DOWING OPHTHALMIC CHAIR AC-POWERED
K Number: K833539
·
Decision Mar 5, 1984
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
15
Applicant Total
3
Review Days
152
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Basic Information
- Device Name
- DOWING OPHTHALMIC CHAIR AC-POWERED
- K Number
- K833539
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1140
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Vision Health Technology
- Date Received
- October 5, 1983
- Decision Date
- March 5, 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 |
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