BP LIMBO XL, BPTANGO XL, BP SALSA XL— 510(k) K072752

Substantially Equivalent

Datadancer Medical Systems

FDA 510(k) clearance K072752 for BP LIMBO XL, BPTANGO XL, BP SALSA XL, Substantially Equivalent on 2008-10-31. Applicant: Datadancer Medical Systems.

Clearance details

Applicant: Datadancer Medical Systems
Product code: Code DQK
Advisory panel: Cardiovascular
Date received: 2007-09-27
Decision date: 2008-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chico, CA, 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.