FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
NIRO-200NX
K Number: K143219
·
Decision Jul 31, 2015
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
73
Applicant Total
8
Review Days
263
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Basic Information
- Device Name
- NIRO-200NX
- K Number
- K143219
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hamamatsu Photonics K.K.
- Date Received
- November 10, 2014
- Decision Date
- July 31, 2015
- Product Code
- MUD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| MUD | Oximeter, Tissue Saturation | FDA class 2 | Cardiovascular |
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