FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SnapshotNIR model KD205
K Number: K240601
·
Decision Apr 2, 2024
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
73
Applicant Total
4
Review Days
29
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SnapshotNIR model KD205
- K Number
- K240601
- 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, Inc.
- Date Received
- March 4, 2024
- Decision Date
- April 2, 2024
- Product Code
- MUD
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- SU
- Third Party
- Y
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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MUD), ordered by most recent decision date.
Spectrum-2
FDA 510(k)
FDA Class 2
·Cardiovascular
Masimo O3 Regional Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
Lap.Ox Laparoscopic Tissue Oximeter
FDA 510(k)
FDA Class 2
·Cardiovascular
Cerebral Autoregulation Index (CAI) Algorithm
FDA 510(k)
FDA Class 2
·Cardiovascular
ODI-Tech
FDA 510(k)
FDA Class 2
·Cardiovascular
OxiplexTS200
FDA 510(k)
FDA Class 2
·Cardiovascular