FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMERICAN MEDICAL OPTICS PHOTOKERATO
K Number: K842128
·
Decision Aug 7, 1984
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
4
Applicant Total
17
Review Days
70
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Basic Information
- Device Name
- AMERICAN MEDICAL OPTICS PHOTOKERATO
- K Number
- K842128
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1350
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- American Medical Optics
- Date Received
- May 29, 1984
- Decision Date
- August 7, 1984
- Product Code
- HJA
- 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 |
|---|---|---|---|
| HJA | Photokeratoscope | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
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Other Clearances by American Medical Optics
| K Number | Device Name | ||
|---|---|---|---|
| K860001 | BARRAQUER-KRUMEICH REFRACTIVE SET | Feb 4, 1986 | Substantially Equivalent |
| K851263 | AMER. MEDICAL OPTIC MONOCULAR DIRECT OPHTHALMASCOP | May 1, 1985 | Substantially Equivalent |
| K851264 | AMER. MEDICAL OPTICS MONOCULAR INDIRECT OPHTHALMAS | May 1, 1985 | Substantially Equivalent |
| K851262 | AMER. MEDICAL OPTICAL BINOCULAR INDIRECT OPHTHALMA | Apr 30, 1985 | Substantially Equivalent |
| K844150 | MEDICAL OPTICS PHACOEMULSIFICATION KIT | Dec 11, 1984 | Substantially Equivalent |
| K843966 | ARGON/KRYPTON LASER PHOTOCOAGULATOR SYS | Nov 8, 1984 | Substantially Equivalent |
| K843965 | ARGON LASER PHOTOCOAGULATOR SYS | Nov 6, 1984 | Substantially Equivalent |
| K842197 | AMERICAN MEDICAL OPTICS I/A KIT- IRRIG | Oct 1, 1984 | Substantially Equivalent |
| K842504 | AMER. MEDICAL OPTICS DIGITAL KERATO- | Oct 1, 1984 | Substantially Equivalent |
| K842127 | AMERICAN MEDICAL OPTICS IMAGING SYS | Sep 7, 1984 | Substantially Equivalent |