FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER
K Number: K100428
·
Decision Jul 9, 2010
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
48
Review Days
143
Basic Information
- Device Name
- MASIMO RAINBOW SET RADICAL 7R PULSE CO-OXIMETER
- K Number
- K100428
- 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
- February 16, 2010
- Decision Date
- July 9, 2010
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQA), ordered by most recent decision date.
Avidhrt Sense SpO2
FDA 510(k)
FDA Class 2
·Cardiovascular
Pulse Oximeter ( PO2, PO2A, PO2B)
FDA 510(k)
FDA Class 2
·Cardiovascular
Aulisa Oximeter Module (2nd Gen.) (GA-OM0007, GA-OM0008)
FDA 510(k)
FDA Class 2
·Cardiovascular
Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U403-91); Unimed Reusable Finger Clip SpO2 Sensors (UXXX-91 Series) (U410-91)
FDA 510(k)
FDA Class 2
·Cardiovascular
AViTA Pulse Oximeter (SP62B)
FDA 510(k)
FDA Class 2
·Cardiovascular
Unimed Reusable Finger Clip SpO2 Sensors (U103-125); Unimed Reusable Finger Clip SpO2 Sensors (U403-254); Unimed Reusable Finger Clip SpO2 Sensors (U103-254); Unimed Reusable Finger Clip SpO2 Sensors (U403-125)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by MASIMO CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K170168 | Masimo Rad-97 and Accessories | Sep 14, 2017 | Substantially Equivalent |
| K162603 | Masimo O3 Regional Oximeter System | May 26, 2017 | Substantially Equivalent |
| K162675 | Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter | Dec 28, 2016 | Substantially Equivalent |
| K160526 | Masimo O3 Regional Oximeter System | Jun 9, 2016 | Substantially Equivalent |
| K151644 | Masimo Root Vital Signs Monitoring System and Accessories | Feb 12, 2016 | Substantially Equivalent |
| K150314 | Masimo MightySat Rx Fingertip Pulse Oximeter | Oct 22, 2015 | Substantially Equivalent |
| K142394 | Masimo Root Monitoring System and Accesories | Nov 25, 2014 | Substantially Equivalent |
| K140188 | MASIMO ROOT MONITORING SYSTEM | Jun 25, 2014 | Substantially Equivalent |
| K120984 | MASIMO RAS-125C ACOUSTIC RESPIRATION SENSOR | Apr 26, 2013 | Substantially Equivalent |
| K120657 | MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS | Sep 19, 2012 | Substantially Equivalent |