MODIFICATION TO: BPCARD, MODEL Z-7000-0700— 510(k) K073630

Substantially Equivalent

Qrs Diagnostic, LLC

FDA 510(k) clearance K073630 for MODIFICATION TO: BPCARD, MODEL Z-7000-0700, Substantially Equivalent on 2008-01-11. Applicant: Qrs Diagnostic, LLC.

Clearance details

Applicant: Qrs Diagnostic, LLC
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 2007-12-26
Decision date: 2008-01-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DXN

product code DXN

Death: 3
Injury: 169
Malfunction: 1,019
Other: 2
Total: 1,193

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.