FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OPHTHALMIC CHAIR
K Number: K844362
·
Decision Dec 11, 1984
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
14
Applicant Total
5
Review Days
28
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Basic Information
- Device Name
- OPHTHALMIC CHAIR
- K Number
- K844362
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1860
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Luneau Laboratories
- Date Received
- November 13, 1984
- Decision Date
- December 11, 1984
- Product Code
- HMF
- 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 |
|---|---|---|---|
| HMF | Stand, Instrument, Ac-Powered, Ophthalmic | FDA class 1 | Ophthalmic |
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