BCI MODEL 6004 NIBP MONITOR (6004)
FDA 510(k) clearance K970801 · decided 1997-11-12
Clearance details
- K-number
- K970801
- Device name
- BCI MODEL 6004 NIBP MONITOR (6004)
- Applicant
- Bci Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-04
- Decision date
- 1997-11-12
- Days to decision
- 253 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- 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 |