FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RS-3000 ADVANCE
K Number: K132323
·
Decision Feb 19, 2014
Classifications
1
FEI Numbers
29
Registration Numbers
30
Same Product Code
65
Applicant Total
20
Review Days
209
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Basic Information
- Device Name
- RS-3000 ADVANCE
- K Number
- K132323
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nidek Co., Ltd.
- Date Received
- July 25, 2013
- Decision Date
- February 19, 2014
- Product Code
- OBO
- 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 |
|---|---|---|---|
| OBO | Tomography, Optical Coherence | FDA class 2 | Ophthalmic |
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