FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
F110 PHOTO BINOCULAR OPHTHALMOSCOPE
K Number: K802351
·
Decision Dec 17, 1980
Classifications
1
FEI Numbers
29
Registration Numbers
30
Same Product Code
2
Applicant Total
1
Review Days
83
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Basic Information
- Device Name
- F110 PHOTO BINOCULAR OPHTHALMOSCOPE
- K Number
- K802351
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1700
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Minami, Tomine & Lew
- Date Received
- September 25, 1980
- Decision Date
- December 17, 1980
- Product Code
- HLG
- 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 |
|---|---|---|---|
| HLG | Pupillometer, Ac-Powered | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HLG), ordered by most recent decision date.
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