MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
FDA 510(k) clearance K033296 · decided 2004-02-19
Clearance details
- K-number
- K033296
- Device name
- MASIMO SET RAD-5 PULSE OXIMETER, MODEL RAD-5; MASIMO SET RAD-5V PULSE OXIMETER, MODEL RAD-5V
- Applicant
- Masimo Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-10-14
- Decision date
- 2004-02-19
- Days to decision
- 128 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 LNOP TC-I SpO2, Reusable Ear Sensor, REF: 1794 recall (Z-1984-2023) | Masimo Corporation | 2023-06-21 |