FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RETCAM 3 OPHTHALMIC IMAGING SYSTEM
K Number: K081858
·
Decision Nov 5, 2008
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
155
Applicant Total
4
Review Days
127
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Basic Information
- Device Name
- RETCAM 3 OPHTHALMIC IMAGING SYSTEM
- K Number
- K081858
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1120
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Clarity Medical Systems
- Date Received
- July 1, 2008
- Decision Date
- November 5, 2008
- Product Code
- HKI
- 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 |
|---|---|---|---|
| HKI | Camera, Ophthalmic, Ac-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Clarity Medical Systems
| K Number | Device Name | ||
|---|---|---|---|
| K102859 | RETCAM 3 OPTHALMIC IMAGING SYSTEM | Apr 20, 2011 | Substantially Equivalent |
| K090326 | RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS | Nov 25, 2009 | Substantially Equivalent |
| K083771 | RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP | Jan 30, 2009 | Substantially Equivalent |