SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
FDA 510(k) clearance K103732 · decided 2011-02-04
Clearance details
- K-number
- K103732
- Device name
- SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR
- Applicant
- Spacelabs Healthcare, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2010-12-22
- Decision date
- 2011-02-04
- Days to decision
- 44 days
- Clearance type
- Special
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Nederland, CO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Ambulatory Blood Pressure (ABP) Monitor, Model 90217A. The Spacelabs Model 90217A Ambulato recall (Z-0304-2012) | Del Mar Reynolds Medical, Ltd. | 2011-11-29 |