PRESSUROMETER II— 510(k) K771500

Substantially Equivalent

Del Mar Avionics

FDA 510(k) clearance K771500 for PRESSUROMETER II, Substantially Equivalent on 1977-08-16. Applicant: Del Mar Avionics.

Clearance details

Applicant: Del Mar Avionics
Product code: Code DXN
Advisory panel: Cardiovascular
Date received: 1977-08-05
Decision date: 1977-08-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.