MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
FDA 510(k) clearance K100403 · decided 2010-06-23
Clearance details
- K-number
- K100403
- Device name
- MASIMO RAINBOW SET PRONTO -7 PULSE CO- OXIMETER AND ACCESSORIES, MODEL PRONTO-7
- Applicant
- Masimo Corporation
- Decision
- Substantially Equivalent
- Date received
- 2010-02-16
- Decision date
- 2010-06-23
- Days to decision
- 127 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 |
|---|---|---|
| Masimo Hemoglobin Pronto-7 with Rainbow 40 Technology for easy-to-use spot-check testing o recall (Z-1387-2011) | Masimo Corporation | 2011-02-22 |