BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER
FDA 510(k) clearance K031742 · decided 2003-08-18
Clearance details
- K-number
- K031742
- Device name
- BCI 6004 NIBP MONITOR WITH NELLCOR PULSE OXIMETER
- Applicant
- Bci, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-04
- Decision date
- 2003-08-18
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| BCI Non Invasive Blood Pressure Monitor Product/Catalog number 6004, recall (Z-1649-2008) | Smiths Medical PM, Inc. | 2008-08-25 |