MODIFICATION TO LNCS OXIMETRY SENSORS
FDA 510(k) clearance K051212 · decided 2005-07-12
Clearance details
- K-number
- K051212
- Device name
- MODIFICATION TO LNCS OXIMETRY SENSORS
- Applicant
- Masimo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2005-05-11
- Decision date
- 2005-07-12
- Days to decision
- 62 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 LNCS TC-I SpO2, Reusable Ear Sensor, REF: 1895 recall (Z-1985-2023) | Masimo Corporation | 2023-06-21 |
| Masimo LNCS TC-I SpO2, Reusable Ear Sensor, REF: 2503 recall (Z-1986-2023) | Masimo Corporation | 2023-06-21 |