MASIMO SET USPO2 PULSE OXIMETRY CABLE
FDA 510(k) clearance K121914 · decided 2012-09-07
Clearance details
- K-number
- K121914
- Device name
- MASIMO SET USPO2 PULSE OXIMETRY CABLE
- Applicant
- Masimo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-07-02
- Decision date
- 2012-09-07
- Days to decision
- 67 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 SET uSpO2 Cable The Masimo SET uSpO2 Pulse Oximetry Cable is an in-line cable that recall (Z-0213-2015) | Masimo Corporation | 2014-11-13 |