FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MASIMO ROOT MONITORING SYSTEM
K Number: K140188
·
Decision Jun 25, 2014
Classifications
1
FEI Numbers
170
Registration Numbers
170
Same Product Code
301
Applicant Total
48
Review Days
152
Basic Information
- Device Name
- MASIMO ROOT MONITORING SYSTEM
- K Number
- K140188
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MASIMO CORPORATION
- Date Received
- January 24, 2014
- Decision Date
- June 25, 2014
- Product Code
- MWI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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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 |
| 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 |
| K121914 | MASIMO SET USPO2 PULSE OXIMETRY CABLE | Sep 7, 2012 | Substantially Equivalent |