Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
FDA 510(k) clearance K201770 · decided 2020-09-24
Clearance details
- K-number
- K201770
- Device name
- Masimo Rad-G Pulse Oximeter, Masimo Rad-G YI sensor, Masimo Rad-G Reusable sensor
- Applicant
- Masimo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-06-29
- Decision date
- 2020-09-24
- Days to decision
- 87 days
- Clearance type
- Special
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Masimo Rad-G, Pulse Oximeter (W/Sensor), REF:9847, Rx Only, recall (Z-1537-2024) | Masimo Corporation | 2024-04-12 |
| Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9849, Rx Only, recall (Z-1538-2024) | Masimo Corporation | 2024-04-12 |