SENSIS, SENSIS LITE— 510(k) K131812

Substantially Equivalent

Siemens Medi Cal Solutions, Inc.

FDA 510(k) clearance K131812 for SENSIS, SENSIS LITE, Substantially Equivalent on 2013-07-25. Applicant: Siemens Medi Cal Solutions, Inc..

Clearance details

Applicant: Siemens Medi Cal Solutions, Inc.
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2013-06-19
Decision date: 2013-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Mavern, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.