K103732 is an FDA 510(k) clearance for the SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Spacelabs Healthcare, Ltd. (Nederland, US). The FDA issued a Cleared decision on February 4, 2011, 44 days after receiving the submission on December 22, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K103732 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2010 |
| Decision Date | February 04, 2011 |
| Days to Decision | 44 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXN - System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |