FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPHTHALMOSCOPE F-10
K Number: K072259
·
Decision May 6, 2008
Classifications
1
FEI Numbers
13
Registration Numbers
14
Same Product Code
21
Applicant Total
20
Review Days
266
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Basic Information
- Device Name
- OPHTHALMOSCOPE F-10
- K Number
- K072259
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nidek Co., Ltd.
- Date Received
- August 14, 2007
- Decision Date
- May 6, 2008
- Product Code
- MYC
- 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 |
|---|---|---|---|
| MYC | Ophthalmoscope, Laser, Scanning | FDA class 2 | Ophthalmic |
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| K181345 | Image Filing Software NAVIS-EX | Jul 19, 2018 | Substantially Equivalent |
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| K170302 | YELLOW LASER PHOTOCOAGULATOR YLC-500 | Jun 23, 2017 | Substantially Equivalent |
| K163564 | SLIT LAMP SL-2000 | May 19, 2017 | Substantially Equivalent |
| K152729 | MICROPERIMETER MP-3 | Jun 6, 2016 | Substantially Equivalent |
| K152603 | Green Laser Photocoagulator GYC-500 | May 2, 2016 | Substantially Equivalent |