MODEL 4810 ANALYZER OUTPUT ADAPTER— 510(k) K002497

Substantially Equivalent

Pace Medical

FDA 510(k) clearance K002497 for MODEL 4810 ANALYZER OUTPUT ADAPTER, Substantially Equivalent on 2000-10-10. Applicant: Pace Medical.

Clearance details

Applicant: Pace Medical
Product code: Code DTC
Advisory panel: Cardiovascular
Date received: 2000-08-14
Decision date: 2000-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTC

product code DTC

Injury: 136
Malfunction: 3,400
Total: 3,536

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.