FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇱 Netherlands
ClarifEye R1.0, ClarifEye Needle
K Number: K201743
·
Decision Feb 23, 2021
Classifications
1
FEI Numbers
118
Registration Numbers
118
Same Product Code
319
Applicant Total
8
Review Days
243
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Basic Information
- Device Name
- ClarifEye R1.0, ClarifEye Needle
- K Number
- K201743
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 892.1650
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Philips Medical Systems Nederlands B.V.
- Date Received
- June 25, 2020
- Decision Date
- February 23, 2021
- Product Code
- OWB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| OWB | Interventional Fluoroscopic X-Ray System | FDA class 2 | Radiology |
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