FDA 510(k)
FDA class 1
Substantially Equivalent
🇫🇷 France
OPHTHALMIC PROJECTOR
K Number: K921214
·
Decision Jun 11, 1992
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
8
Applicant Total
3
Review Days
90
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Basic Information
- Device Name
- OPHTHALMIC PROJECTOR
- K Number
- K921214
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1680
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Luneau Ophtalmologie SA
- Date Received
- March 13, 1992
- Decision Date
- June 11, 1992
- Product Code
- HOS
- 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 |
|---|---|---|---|
| HOS | Projector, Ophthalmic | FDA class 1 | Ophthalmic |
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