NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN
FDA 510(k) clearance K123581 · decided 2013-05-09
Clearance details
- K-number
- K123581
- Device name
- NELLCOR OXIMAX N-600X PULSE OXIMETER, NELLCOR BEDSIDE RESPIRATORY PATIENT MONITORING SYSTEM, NELLCOR BEDSIDE SPO2 PATIEN
- Applicant
- Covidien, Formerly Nellcor Puritan Bennett, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-11-20
- Decision date
- 2013-05-09
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Boulder, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OxiMax N-65 Handheld Pulse Oximeter. N65, N65-1, N65P, and N65P-1. For continuous or spot recall (Z-2267-2015) | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | 2015-07-27 |
| OxiMax N-560 Pulse Oximeter. For continuous or spot check monitoring of functional arteria recall (Z-2268-2015) | Covidien LP (formerly Nellcor Puritan Bennett Inc.) | 2015-07-27 |