The following data is part of a premarket notification filed by Spacelabs Healthcare Ltd. with the FDA for Spacelabs Model 90217a Ambulatory Blood Pressure (abp) Monitor.
| Device ID | K103732 |
| 510k Number | K103732 |
| Device Name: | SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SPACELABS HEALTHCARE LTD. PO BOX 3018 Nederland, CO 80466 |
| Contact | Thomas Kroenke |
| Correspondent | Thomas Kroenke SPACELABS HEALTHCARE LTD. PO BOX 3018 Nederland, CO 80466 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-22 |
| Decision Date | 2011-02-04 |
| Summary: | summary |