SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR— 510(k) K103732
Substantially EquivalentSpacelabs Healthcare, Ltd.
FDA 510(k) clearance K103732 for SPACELABS MODEL 90217A AMBULATORY BLOOD PRESSURE (ABP) MONITOR, Substantially Equivalent on 2011-02-04. Applicant: Spacelabs Healthcare, Ltd.. Device class: 2.
Clearance details
- Applicant
- Spacelabs Healthcare, Ltd.
- Product code
- Product code DXN
- Device class
- Class 2
- Regulation
- 21 CFR 870.1130
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Nederland, CO, US
Recent devices under product code DXN
view all- K260670 — YUWELL® Electronic Blood Pressure Monitor
- K260470 — Electronic Blood Pressure Monitor (BP-204C, BP-204A, BP-215, BP-203C, BP-205A, BP-201C, BP-217, BP-202C, BP-202 BP-205, BP-205B,BP-206)
- K261929 — Upper Arm Blood pressure monitor (BP7155D)
- K254000 — Happy Health Blood Pressure Monitor
- K262658 — Automatic Digital Blood Pressure monitor (LD-526)
More clearances from Spacelabs Healthcare, Ltd.
view allAdverse events under product code DXN
product code DXN- Death
- 3
- Injury
- 169
- Malfunction
- 1,019
- Other
- 2
- Total
- 1,193
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.