Masimo Rad-G with Temperature
FDA 510(k) clearance K213676 · decided 2023-04-16
Clearance details
- K-number
- K213676
- Device name
- Masimo Rad-G with Temperature
- Applicant
- Masimo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2021-11-22
- Decision date
- 2023-04-16
- Days to decision
- 510 days
- Clearance type
- Traditional
- 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 with temperature (W/Sensor), REF:9210, Rx Only, recall (Z-1536-2024) | Masimo Corporation | 2024-04-12 |
| Masimo Rad-G, Pulse Oximeter (W/Patient Cable), REF:9895 Rx Only, recall (Z-1539-2024) | Masimo Corporation | 2024-04-12 |