FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L
K Number: K081659
·
Decision Sep 9, 2008
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
48
Review Days
89
Basic Information
- Device Name
- RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L
- K Number
- K081659
- 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
- June 12, 2008
- Decision Date
- September 9, 2008
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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