SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER— 510(k) K001995

Substantially Equivalent

Qrs Diagnostic, LLC

FDA 510(k) clearance K001995 for SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER, Substantially Equivalent on 2000-09-08. Applicant: Qrs Diagnostic, LLC.

Clearance details

Applicant: Qrs Diagnostic, LLC
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2000-06-30
Decision date: 2000-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Plymouth, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.