FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IVUE 500
K Number: K133892
·
Decision Mar 19, 2014
Classifications
1
FEI Numbers
51
Registration Numbers
51
Same Product Code
86
Applicant Total
13
Review Days
89
Basic Information
- Device Name
- IVUE 500
- K Number
- K133892
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- OPTOVUE, INC.
- Date Received
- December 20, 2013
- Decision Date
- March 19, 2014
- Product Code
- HLI
- 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 |
|---|---|---|---|
| HLI | Ophthalmoscope, Ac-Powered | FDA class 2 | Ophthalmic |
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|---|---|---|---|
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| K120238 | RTVUE XR OCT | Apr 3, 2012 | Substantially Equivalent |
| K111505 | RTVUE CAM WITH CORNEAL POWER UPGRADE | Sep 8, 2011 | Substantially Equivalent |
| K103266 | ISTAND | Jun 3, 2011 | Substantially Equivalent |
| K101505 | RTVUE MODEL RTVUE 100 | Sep 15, 2010 | Substantially Equivalent |
| K100861 | R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100 | Jun 17, 2010 | Substantially Equivalent |
| K091404 | IVUE, MODEL 100 | Apr 22, 2010 | Substantially Equivalent |