BCI MINI-TORR PLUS, MODEL 6004
FDA 510(k) clearance K984618 · decided 1999-03-25
Clearance details
- K-number
- K984618
- Device name
- BCI MINI-TORR PLUS, MODEL 6004
- Applicant
- Bci Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-29
- Decision date
- 1999-03-25
- Days to decision
- 86 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
+ Add to Predicate Builder ◉ Watch Bci Intl.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |