RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20
FDA 510(k) clearance K090165 · decided 2009-07-09
Clearance details
- K-number
- K090165
- Device name
- RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20
- Applicant
- Masimo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2009-01-22
- Decision date
- 2009-07-09
- Days to decision
- 168 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
No recalls on record reference this clearance.