FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Masimo O3 Regional Oximeter
K Number: K243324
·
Decision Jul 17, 2025
Classifications
1
FEI Numbers
58
Registration Numbers
58
Same Product Code
73
Applicant Total
85
Review Days
267
Basic Information
- Device Name
- Masimo O3 Regional Oximeter
- K Number
- K243324
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Masimo Corporation
- Date Received
- October 23, 2024
- Decision Date
- July 17, 2025
- 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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