FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SnapshotNIR
K Number: K201976
·
Decision Nov 10, 2020
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
71
Applicant Total
1
Review Days
117
Basic Information
- Device Name
- SnapshotNIR
- K Number
- K201976
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kent Imaging
- Date Received
- July 16, 2020
- Decision Date
- November 10, 2020
- Product Code
- MUD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- SU
- 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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