MASIMO SET RAD 57 PULSE CO-OXIMETER
FDA 510(k) clearance K042536 · decided 2005-01-19
Clearance details
- K-number
- K042536
- Device name
- MASIMO SET RAD 57 PULSE CO-OXIMETER
- Applicant
- Masimo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2004-09-20
- Decision date
- 2005-01-19
- Days to decision
- 121 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 |
|---|---|---|
| Rainbow DC-I-DC Pulse CO-Oximeter Sensor used with the Masimo SET Rad 57 Pulse CoOximeter recall (Z-0661-06) | Masimo Corporation | 2006-03-18 |