Spacelabs 90217A
Device Model:
90217A
Manufacturer:
Spacelabs Healthcare, 35301 SE Center St., Snoqualmie, WA 98065, UNITED STATES.
Measuring functions:
Blood pressure
Primary Client Use:
Intended for ambulatory blood pressure monitoring
Measurement Site:
Upper Arm
Measurement Occurrence:
Intermittent measurements at specified intervals or times
Availability:
Available Currently
Description:
The Spacelabs 90217A is an ambulatory blood pressure monitor. Medaval has not found evidence proving the accuracy of its blood pressure measurement technology. Blood pressure measurements are taken from the upper arm. It is intended for ambulatory blood pressure monitoring.
Assessment:
There appears to be no peer-reviewed clinical validation information available on the technology used in the Spacelabs 90217A to measure blood pressure.
Recommendations:
| Accuracy Assessment | Recommendation | Basis | |
| BP | Medaval | Not recommended | This device has not been clinically validated. |
| BP | FDA (US) | 510(k) | 510(k) K103732 |
Relevant Publications:
Sarafidis PA, Lazaridis AA, Imprialos KP, Georgianos PI, Avranas KA, Protogerou AD, Doumas MN, Athyros VG, Karagiannis AI. A comparison study of brachial blood pressure recorded with Spacelabs 90217A and Mobil-O-Graph NG devices under static and ambulatory conditions. J Hum Hypertens. 2016 Dec;30(12):742-9. Epub: 2016 Mar 3. doi: 10.1038/jhh.2016.11. PMID: 26935286.
Measurements from the Spacelabs 90207A are compared to those from the IEM Mobil-O-Graph NG and a standard mercury sphygmomanometer, though not in a formal validation.